90 results on '"Jeffrey E Carter"'
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2. Bismuth/petroleum gauze plus high density polyethylene vs. bismuth/petroleum gauze: A comparison of donor site healing and patient comfort
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Christopher K. Craig, Jeffery W. Williams, Jeffrey E. Carter, and James. H. Holmes
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Petroleum ,Polyethylene ,Emergency Medicine ,Humans ,Surgery ,Skin Transplantation ,General Medicine ,Patient Comfort ,Burns ,Critical Care and Intensive Care Medicine ,Bandages ,Bismuth ,Retrospective Studies - Abstract
Skin grafting continues to be a fundamental component of burn treatment and inherently, a donor site must be created and treated. Burn surgeons agree that specific dressings may have a significant affect on donor site healing, but we have no consensus as to which dressing provides maximum benefit.Retrospective analysis of prospectively collected data from an observational, within-patient controlled assessment of a practice pattern intervention. The project compared donor sites treated with high-density polyethylene plus an overlying layer of bismuth/petroleum gauze to donor sites treated with bismuth/petroleum gauze alone. The primary endpoint was patient reported pain using a standard visual analog scale from 0 (no pain) to 10 (worst possible pain). A 2-point reduction in pain was considered clinically significant. Healing was defined as complete detachment of the dressings and 95% wound re-epitheliazation.A total of 30 patients were observed and analyzed. Both dressings were associated with a mean pain rating of 6 out of 10 (STD= ± 2) and a median pain rating of 6 out of 10 (range = 0-10). Additionally, both dressings were associated with a mean healing time of 20 days (SEM=1.1). The subjective dressing preference showed that a majority of patients had no preference between the two modalities (n = 20). However, when an actual preference was stated (n = 10), bismuth/petroleum gauze alone was preferred by 9 out of 10 patients.Clinically and subjectively, we found no discernible differences between the 2 dressing regimens. Thus, bismuth/petroleum gauze alone is the more cost effective dressing choice. Our burn center continues to use bismuth/petroleum gauze alone as its standard of care for donor site dressings and will continue to try to define the optimal donor site dressing.
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- 2022
3. Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns
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James H, Holmes Iv, Leopoldo C, Cancio, Jeffrey E, Carter, Lee D, Faucher, Kevin, Foster, Helen D, Hahn, Booker T, King, Randi, Rutan, Janice M, Smiell, Richard, Wu, and Angela L F, Gibson
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Adult ,Soft Tissue Injuries ,Pruritus ,Emergency Medicine ,Humans ,Surgery ,Skin Transplantation ,General Medicine ,Burns ,Critical Care and Intensive Care Medicine ,Transplantation, Autologous - Abstract
This analysis includes pooled safety data from 2 clinical trials (NCT01437852; NCT03005106) that evaluated the safety and efficacy of StrataGraft in patients with deep partial-thickness (DPT) burns.The study enrolled 101 adult patients with thermal burns covering 3-49% of total body surface area. Patients were followed for up to 1 year. The pooled safety events included: adverse events (AEs), adverse reactions (ARs), serious AEs (SAEs), discontinuation, and deaths; immunological responses (reactivity to panel reactive antibodies [PRA] and human leukocyte antigen [HLA] class 1 alleles); and persistence of allogeneic DNA from StrataGraft.Eighty-seven (86.1%) patients experienced 397 AEs. Thirty patients (29.7%) experienced ARs; 16 patients (15.8%) experienced SAEs. The most frequent AEs were pruritus (n = 31; 30.7%), and blister, hypertension, and hypertrophic scar (n = 11 each; 10.9%); the most common AR was pruritus (n = 13; 12.9%). One patient discontinued the study; 2 patients experienced SAEs (unrelated to StrataGraft) leading to death. PRA and HLA allele reactivity was ≤ 25% at Month 3, with no persistent allogeneic DNA from StrataGraft.StrataGraft was well tolerated by patients, with a safety profile similar to autograft. StrataGraft may offer a safe alternative to autograft for DPT burns.
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- 2022
4. Clinical Investigation of a Rapid Non-invasive Multispectral Imaging Device Utilizing an Artificial Intelligence Algorithm for Improved Burn Assessment
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Jeffrey E Thatcher, Faliu Yi, Amy E Nussbaum, John Michael DiMaio, Jason Dwight, Kevin Plant, Jeffrey E Carter, and James H Holmes
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Currently, the incorrect judgment of burn depth remains common even among experienced surgeons. Contributing to this problem are change in burn appearance throughout the first week requiring periodic evaluation until a confident diagnosis can be made. To overcome these issues, we investigated the feasibility of an artificial intelligence algorithm trained with multispectral images of burn injuries to predict burn depth rapidly and accurately, including burns of indeterminate depth. In a feasibility study, 406 multispectral images of burns were collected within 72 hours of injury and then serially for up to 7 days. Simultaneously, the subject’s clinician indicated whether the burn was of indeterminate depth. The final depth of burned regions within images were agreed upon by a panel of burn practitioners using biopsies and 21-day healing assessments as reference standards. We compared three convolutional neural network architectures and an ensemble in their capability to automatically highlight areas of nonhealing burn regions within images. The top algorithm was the ensemble with 81% sensitivity, 100% specificity, and 97% positive predictive value (PPV). Its sensitivity and PPV were found to increase in a sigmoid shape during the first week postburn, with the inflection point at day 2.5. Additionally, when burns were labeled as indeterminate, the algorithm’s sensitivity, specificity, PPV, and negative predictive value were: 70%, 100%, 97%, and 100%. These results suggest multispectral imaging combined with artificial intelligence is feasible for detecting nonhealing burn tissue and could play an important role in aiding the earlier diagnosis of indeterminate burns.
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- 2023
5. A Risk-Benefit Review of Currently Used Dermal Substitutes for Burn Wounds
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David M Hill, William L Hickerson, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
While split-thickness autologous skin grafts remain the most common method of definitive burn wound closure, dermal substitutes have emerged as an attractive option. There are many advantages of utilizing a dermal substitute, notably reducing the need for donor tissue and subsequent iatrogenic creation of a secondary wound. However, there are disadvantages with each that most be weighed and factored into the decision. And most come at a high initial financial cost. There is little comparative literature of the various available and emerging products. This analysis was performed to objectively present risks and benefits of each option.
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- 2022
6. Use of Autologous Skin Cell Suspension for the Treatment of Hand Burns: A Pilot Study
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Charles T Tuggle, Scott A. Barnett, and Jeffrey E Carter
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medicine.medical_specialty ,Graft failure ,business.industry ,medicine.medical_treatment ,Healing time ,Burn center ,Mean age ,Surgery ,Skin cell ,Chart review ,medicine ,Skin grafting ,business ,Total body surface area - Abstract
Purpose Autologous skin cell suspension (ASCS) is a valid alternative and adjunct to split-thickness skin grafting (STSG) for treating burns. Limited data exists regarding the use of ASCS for hand burns. We hypothesized that using ASCS in hand burns shortens healing time with no difference in complications and less donor site morbidity. Methods This was a retrospective chart review of second- and third-degree hand burns treated at a level 1 Trauma and Burn Center from 2017 to 2019. Study groups included patients with hand burns treated with ASCS in combination with STSG and those treated with STSG alone. Outcomes included time to re-epithelialization, return to work, length of hospital stay, and complications including reoperation, graft failure, and infection. Results Fifty-nine patients aged 14 to 85 years (mean age 39 ± 15 years) met inclusion criteria. The ASCS treatment group comprised 37 patients; STSG comprised 22 patients. Mean follow-up time was 14 ± 7 months. The ASCS treatment group had a larger mean percent total body surface area (TBSA) (22% ± 14% vs 6% ± 8%; P Conclusions ASCS is safe and effective in treating hand burns. ASCS was associated with similar rates of re-epithelialization, earlier return to work, and no difference in complications compared with STSG. Type of study/level of evidence: Therapeutic IV.
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- 2021
7. Length of Stay and Costs with Autologous Skin Cell Suspension Versus Split-Thickness Skin Grafts: Burn Care Data from US Centers
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Jeffrey E. Carter, Joshua S. Carson, William L. Hickerson, Lisa Rae, Syed F. Saquib, Lucy A. Wibbenmeyer, Russell V. Becker, Thomas P. Walsh, and Jeremiah A. Sparks
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Adult ,Male ,Humans ,Pharmacology (medical) ,Female ,General Medicine ,Skin Transplantation ,Length of Stay ,Administration, Cutaneous ,Transplantation, Autologous ,Retrospective Studies ,Skin - Abstract
Autologous skin cell suspension (ASCS) significantly reduces donor skin requirements versus conventional split-thickness skin grafts (STSG) for thermal burn treatment. In analyses using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model, ASCS was associated with shorter hospital length of stay (LOS) and cost savings versus STSG. This study hypothesized that daily practice data from the USA would support these findings.Electronic medical record data from 500 healthcare facilities (January 2019-August 2020) were used to match adult patients who received inpatient burn treatment with ASCS (± STSG) to patients treated with STSG alone on the basis of sex, age, percent total body surface area (TBSA), and comorbidities. Based on BEACON analyses, LOS was assumed to represent 70% of total costs and used as a proxy to assess the data. Mean LOS, costs, and the incremental revenue associated with inpatient capacity changes were calculated.A total of 151 ASCS and 2443 STSG patients were identified: 63.0% were male and average age was 44.5 years. Eight-one matches were made between cohorts. LOS was 21.7 days with ASCS and 25.0 days with STSG alone (difference 3.3 days [13.2%]). LOS was lower with ASCS than STSG in four of five TBSA intervals. The LOS difference led to hospital bed cost savings of $25,864 per ASCS patient; overall cost savings were $36,949 per patient. Similar cost savings were observed in TBSA groupings 20% and ≥ 20%. The reduced LOS with ASCS translated into an increased capacity of 2.2 inpatients/bed annually, which increased hospital revenue by $92,283/burn unit bed annually.Real-world data show that ASCS (± STSG) is associated with reduced LOS and cost savings versus STSG alone across all burn sizes, supporting the validity of the BEACON analyses. ASCS use may also increase patient capacity and throughput, leading to increased hospital revenue.Autologous skin cell suspension (ASCS) is a treatment for thermal skin burn injuries that can be used alone or in combination with split-thickness skin grafts (STSG), the conventional standard of care. Projections using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model indicate that ASCS leads to shorter hospital length of stay (LOS) and overall cost savings compared with STSG alone. These model findings are supported by benchmarking study data from a limited sample of US burn centers. The current study aimed to understand whether the BEACON projections are supported by daily clinical practice data from US healthcare facilities. Using electronic medical record data, we matched patients who received ASCS ± STSG from January 2019 to August 2020 to those receiving STSG alone on the basis of demographic and clinical factors. Data analysis showed that hospital LOS was shorter (3.3 days) with ASCS ± STSG than STSG alone, a difference associated with a hospital bed cost savings of $25,864 per ASCS patient. Overall cost savings, which included nursing time and other costs, were $36,949 per patient. Analysis of patients with burns comprising total body surface areas less than 20% or at least 20% showed cost savings in both groups. The reduced LOS with ASCS also translated into the ability to treat 2.2 more patients per hospital bed per year, which was projected to increase hospital earnings. These real-world findings support those of modeling analyses, indicating that use of ASCS ± STSG is associated with meaningful clinical and economic benefits compared with use of STSG alone.
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- 2022
8. Updating the Burn Center Referral Criteria: Results From the 2018 eDelphi Consensus Study
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Yuk Ming Liu, William L. Hickerson, Kathleen S Romanowski, James C. Jeng, Jeffrey E Carter, Amanda P Bettencourt, Renata Fabia, Gary Vercruysse, John T. Schulz, Robert Cartotto, Colleen M. Ryan, Victor Joe, and Christopher K Craig
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Patient Transfer ,Burn injury ,Telemedicine ,Consensus ,Delphi Technique ,Referral ,Burn Units ,Clinical Decision-Making ,MEDLINE ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,Referral and Consultation ,Burn therapy ,business.industry ,Patient Selection ,Rehabilitation ,030208 emergency & critical care medicine ,Burn center ,Original Articles ,medicine.disease ,Triage ,Clinical trial ,Emergency Medicine ,Surgery ,Medical emergency ,Burns ,business - Abstract
Existing burn center referral criteria were developed several years ago, and subsequent innovations in burn care have occurred. Coupled with frequent errors in the estimation of extent of burn injury and depth by referring providers, patients are both over and under-triaged when the existing criteria are used to support patient care decisions. In the absence of compelling clinical trial data on appropriate burn patient triage, we convened a multidisciplinary panel of experts to execute an iterative eDelphi consensus process to facilitate a revision. The eDelphi process panel consisted of n = 61 burn stakeholders and experts and progressed through four rounds before reaching consensus on key clinical domains. The major findings are that 1) burn center consultation is strongly recommended for all patients with deep partial-thickness or deeper burns ≥ 10% TBSA burned, for full-thickness burns ≥ 5% TBSA burned, for children and older adults with specific dressing and medical needs, and for special burn circumstances including electrical, chemical, and radiation injuries; 2) smaller burns are ideally followed in burn center outpatient settings as soon as possible after injury, preferably without delays of a week or more; 3) frostbite, Stevens–Johnson syndrome/TENS, and necrotizing soft-tissue infection patients benefit from burn center treatment; and 4) telemedicine and technological solutions are of likely benefit in achieving this standard. Unlike the original criteria, the revised consensus-based guidelines create a framework promoting communication so that triage and treatment are specifically tailored to individual patient characteristics, injury severity, geography, and the capabilities of referring institutions.
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- 2020
9. Initial Experience With Autologous Skin Cell Suspension for Treatment of Deep Partial-Thickness Facial Burns
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James H. Holmes, Jeffrey W Williams, Nicholas J Walker, Jeffrey E Carter, Thomas N. Steele, Christopher K Craig, and Joseph A. Molnar
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Adult ,Compassionate Use Trials ,Male ,medicine.medical_specialty ,Cell Transplantation ,Graft loss ,Transplantation, Autologous ,Superficial hematoma ,Dermis ,medicine ,Humans ,In patient ,Prospective Studies ,Major complication ,Child ,Facial Injuries ,business.industry ,Rehabilitation ,Epithelial Cells ,Burn center ,Skin Transplantation ,Surgery ,Treatment Outcome ,medicine.anatomical_structure ,Skin cell ,Child, Preschool ,Emergency Medicine ,Female ,Burns ,business ,Partial thickness - Abstract
Facial burns present a challenge in burn care, as hypertrophic scarring and dyspigmentation can interfere with patients’ personal identities, ocular and oral functional outcomes, and have long-term deleterious effects. The purpose of this study is to evaluate our initial experience with non-cultured, autologous skin cell suspension (ASCS) for the treatment of deep partial-thickness (DPT) facial burns. Patients were enrolled at a single burn center during a multicenter, prospective, single-arm, observational study involving the compassionate use of ASCS for the treatment of large total BSA (TBSA) burns. Treatment decisions concerning facial burns were made by the senior author. Facial burns were initially excised and treated with allograft. The timing of ASCS application was influenced by an individual’s clinical status; however, all patients were treated within 30 days of injury. Outcomes included subjective cosmetic parameters and the number of reoperations within 3 months. Five patients (4 males, 1 female) were treated with ASCS for DPT facial burns. Age ranged from 2.1 to 40.7 years (mean 18.2 ± 17.3 years). Average follow-up was 231.2 ± 173.1 days (range 63–424 days). Two patients required reoperation for partial graft loss within 3 months in areas of full-thickness injury. There were no major complications and one superficial hematoma. Healing and cosmetic outcomes were equivalent to, and sometimes substantially better than, outcomes typical of split-thickness autografting. Non-cultured, ASCS was successfully used to treat DPT facial burns containing confluent dermis with remarkable cosmetic outcomes. Treatment of DPT burns with ASCS may be an alternative to current treatments, particularly in patients prone to dyspigmentation, scarring sequelae, and with limited donor sites.
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- 2020
10. 50 Rise of the (Learning) Machines: Artificial Intelligence for the Assessment of Adult Thermal Burns
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Jeffrey E Carter, Herb A Phelan, William L Hickerson, J Michael DiMaio, Jeffrey W Shupp, and James H Holmes
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Burn depth assessment (BDA) is an essential component of the physical exam used in the treatment and triage of burn injured patients. And while many specialties incorporate labs and imaging to determine diagnoses, burn professionals must rely on a physical exam that is accurate in only 70-80% of cases. Our goal was to assess the accuracy of a new imaging technology called Multispectral imaging (MSI) combined with a machine learning algorithm to aid in rapid BDA. We present the results of the first multi-center study using this technology in adult burn injuries. Methods In a multi-center IRB-approved study, an MSI device was used to image subjects >18 years of age with thermal burn injuries. The imaging device captured a set of images measuring the reflectance of visible and near-IR light. Subjects were enrolled and imaged within 72 hours of injury with serial imaging as permitted. The images were used to develop a type of machine learning algorithm called a convolutional neural network (CNN) that could identify the regions of non-healing burn within an image. Non-healing burn areas were determined by a panel of three burn surgeons using two standards: a) images confirming 21-day spontaneous healing; or b) pathology reports detailing histologic changes from multiple punch biopsies taken prior to burn excision. From this data, an ensemble of eight separate CNN algorithms was used to automatically identify non-healing burn tissue. Training and test accuracies of the ensemble CNN were calculated using cross-validation at the level of the subject. Results One hundred (100) adults were enrolled and imaged. The population had a mean age 45.6 ± 16.7; mean TBSA 13.0 ± 9.3; and was 31% female. From these adults, 210 burn regions were serially imaged. The estimated performance result from the ensemble CNN for identification of non-healing burn regions was AUC of 0.96. Based on the ROC curve, an ideal threshold showed an accuracy of 92.0%, sensitivity 91.9%, and specificity 92.0%. Conclusions Our study demonstrates a non-invasive technology that rapidly determines an accurate DBA relative to traditional bedside exam. More accurate burn wound assessment could lead to avoiding unnecessary surgeries or delays in treatment and dramatic cost savings. Use of such a device in a disaster has additional value to better align a patient’s burn care needs and available resources.
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- 2022
11. 570 Burn-Related Injuries Treated at Two Gulf Coast Hospitals During Following a Category 4 Hurricane
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Nicole M Kopari, Mario Rivera, Herb A Phelan, Randy D Kearns, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Natural disasters are commonly associated with mass destruction and severe injuries. On August 29th, 2021 a category 4 hurricane made landfall before mandatory evacuations were ordered in a major metropolitan community. The powerful storm challenged disaster management teams and first responders as communities struggled to recover. Our study analyzes the demographics of those injured and the injury patterns treated at our state’s only verified burn/trauma center and the adjacent children’s hospital in the aftermath of the hurricane. Methods A retrospective chart review was performed on patients seeking emergent care following the hurricane. Demographic data was abstracted from the medical records along with injury pattern including age, gender, mechanism of injury, total body surface area (TBSA), surgical interventions, and length of stay. In addition, brief surveys of fire chiefs from the two most impacted regions were performed to assess prehospital challenges. Results 41 patients (76% male) presented to our ER with a median age of 44 (7 patients < 12 years of age). 85% of injuries occurred at home while 15% occurred at work. Of the 78% requiring admission, 66% underwent excision and autograft with a mean TBSA of 17% (range 1-80%). Power outages resulted in increased gas generator usage across the region. Most of the burn injuries following the storm were due to generator and cooking accidents (56%). Each fire chief reported up to 91 calls/day due to suspected carbon monoxide poisoning for the two weeks following the storm. A single event resulted in 8 inhalation injuries treated in our ER with one burn ICU admission. The mean hospital length of stay was 1.11 days/%TBSA for those undergoing surgery. Conclusions Hurricanes are more common today with many coastal cities as risk for similar natural disasters. Despite our generator safety media outreach efforts prior to the storm, this remains an opportunity for improved injury prevention. Many patients suffered delays in discharge as their homes/nursing facilities suffered structural damages and were without power and water. Disaster planning should account for limited disposition options during severe storms. Our study is the first to describe burn-related injuries from a category 4 storm and our communities’ response.
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- 2022
12. 543 Challenges in Burn Nurse and Therapy Staffing During and After a Category 4 Hurricane
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Abbey Peterson, Desiree Compton, Dana Y Nakamura, Jeremy Landry, Aimee Keating, Nicole M Kopari, Jeffrey E Carter, and Herb A Phelan
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Burn nurse/therapy staffing has been stretched for months by the pandemic. Along the Gulf Coast, Hurricane Ida recently taxed these resources further as regional burn centers saw a weeks-long surge in serious burn injuries in the setting of prolonged power and water outages. We reviewed the execution of a plan for the provision of burn nurse/therapist staffing at an ABA-verified adult burn center that experienced a direct hit by a Category 4 storm. Methods Hospital leadership planned to activate Code Gray on 8/29/21 at which time the hospital would be placed on lockdown with no one allowed in or out until Code Gray was lifted. Our burn leadership subsequently designed a plan to have ten burn nurses and one Occupational Therapist (TEAM A) in house from the inception of Code Gray at 7am on 8/29 thru 7am on 9/1. If Code Gray conditions persisted, nine dedicated burn nurses (TEAM B) were to relieve TEAM A. TEAM B was planned to remain in-house until 7am on 9/4. If Code Gray conditions continued, the plan was to be reassessed at that time. The same burn therapist was planned to remain in-house throughout. Physician coverage was to be provided by the in-house trauma team during Code Gray. No housing or bedding was provided for in-house personnel, and the hospital generator system ostensibly had a 30-day fuel supply. Results TEAM A day/night staffing was 6/4 with the off crew sleeping in conference rooms and clinic spaces. An unexpected event occurred when a mission-critical tower for the city’s grid toppled into a river resulting in delays for restoration of the grid, and city-wide boil-water and burn-ban policies. As generators came into widespread use, our pre-storm census of 9 increased to a mean of 12.7 + 1.4. Due to this increase, on the morning of 9/1 six TEAM A nurses elected to stay and be absorbed into Team B with day/night staffing of 6/6. The rapid influx in number and complexity of burn patients made it clear a burn surgeon presence was needed during Code Gray. One burn attending was able to make it to the hospital at 7am on 8/30 and worked until being relieved at 7am on 9/5. An informal triage strategy was enacted in which only burns of >10% TBSA would be considered for admission. OR availability went down to 2 + 1 at the inception of Code Gray and 3 + 1 on 9/6. Eleven cases were done during this time with a mean TBSA of 20.2 + 10.7%. Hospital generators were found to consume fuel at a rate almost twice predicted. Due to prioritization, the hospital went back on city power on 9/2. Code Gray was lifted at 7am on 9/4 and normal operations resumed at 7am on 9/11. Conclusions The successful provision of care required a willingness for nurses and one therapist to remain in the hospital for six consecutive days and for hospital administration to approve the overtime.
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- 2022
13. 52 Refinement of a Histologic Algorithm for Burn Depth Categorization Using 1142 Consecutive Burn Wound Biopsies
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Herb A Phelan, James H Holmes, William L Hickerson, Clay J Cockerell, Jeffrey W Shupp, J Michael DiMaio, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Our group previously reported a theoretical burn biopsy algorithm (BBA-V1) for the categorization of burn wound depth based on histologic analysis, and informed it with the largest series of burn wound biopsies in the literature. That iteration of the BBA resulted in clinical misclassification rates consistent with past literature. Since our last report of that process, we have refined the algorithm with new criteria and a larger repository of burn wound biopsies. Here, we sought to promulgate this newer, simpler version of the BBA (BBA-V2). Methods This was an IRB-approved, prospective, multicenter study. Patients with burn wounds assessed by burn experts as requiring excision and autograft underwent 4mm biopsies procured every 25cm2. Serial still photos were obtained at enrollment and at excision intraoperatively. Using H&E with whole slide scanning, a board-certified dermatopathologist assessed each burn biopsy. The criteria used for categorization of burn wound depth in BBA-V1 were: 1) proportion of necrotic adnexal structures, and 2) presence/absence of each of epidermis, papillary dermis, and reticular dermis. The criteria used for BBA-V2 were: 1) magnitude of reticular dermal degeneration, 2) proportion of necrotic adnexal structures, and 3) magnitude of vessel thrombosis. Biopsy pathology results were correlated with still photos by 3 burn experts for consensus of final burn depth diagnosis. Superficial partial thickness (SPT) wounds were considered to be burn wounds likely to have healed without surgery, while deep partial thickness (DPT) and full thickness (FT) were considered unlikely to heal by 21 days. Results The development of BBA V-1 was previously informed by 66 subjects with 117 wounds and 816 biopsies, and resulted in wound categorizations as follows: SPT (20%), DPT (43%), and FT (37%). Therefore, according to BBA-V1, 20% of burn wounds were incorrectly judged as needing excision and grafting by the clinical team. The overall cohort was enlarged to 162 subjects with 294 wounds and 1142 biopsies. The most recent 838 burn wound biopsies were then re-reviewed and re-categorized according to the new BBA-V2 criteria and algorithm. Under BBA-V2, 3% of all burn wound biopsies were categorized as superficial partial thickness, 69% were categorized as deep partial thickness, and 29% were categorized as full thickness. Conclusions Our study demonstrates that by adding dermal degeneration severity and vessel thrombosis to our previous criterion of adnexal structure necrosis, BBA-V2 had a much higher rate of concordance with visual clinical assessment for burn wounds clinically judged as needing surgical excision. This study serves as the largest analysis of burn biopsies by modern day burn experts.
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- 2022
14. 793 'Minimally Invasive' Skin Grafting with Enzymatic Debridement and Autologous Skin Cell Suspension
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Steven A Kahn, Gabriel G Gaweda, Elizabeth Halicki, Jason Hirsch, Ashley Hink, William L Hickerson, James H Holmes, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Minimally invasive surgery has become standard of care across numerous subspecialties. However, burn surgery has lagged behind; as the mainstay of treatment still involves excision with a knife and a split thickness skin graft (STSG) with a painful donor site. Enzymatic debridement with bromelain and autologous skin cell spray (ASCS) have independently been STSG use and decrease the donor site size. Due to constraints with the time course of these products only being available via studies before one was FDA approved, these technologies have not been utilized together in the United States until recently. Little literature exists regarding their use in combination. The current study characterizes a series of patients who received “minimally invasive” skin grafts with enzymatic debridement and ASCS as proof of concept. Methods This was a retrospective study of a single academic burn center’s experience using bromelain and ASCS together. Data collection included demographics, injury characteristics, length of stay, complications, and measurements of donor sites, STSGs, and ASCS treatment. Donor site size:total area treated with ASCS and/or STSG was calculated. Length of stay (LOS) was qualitatively compared to expected using a factor of 1.1days:%TBSA, and O/E LOS ratio was calculated. Data was reported in medians with interquartile ranges. Patients with 1-30%TBSA qualified for the bromelain study and were treated according to protocol. Those deemed to have enough residual dermis were treated with ASCS, while 3rd degree areas received meshed split thickness skin patch grafts with ASCS overspray. Results Eleven patients were included in the study. Four patients received ASCS alone, while 7 patients received a meshed STSG on portions of their burn. Median burn size was 13% TBSA (IQR:5,20), while DPT+FT size was 9% TBSA (IQR:5,16). Patients had a median of 1067 sq cm (IQR:772,2183) of burn operatively treated with ASCS, and 351 sq cm (IQR:0,457) treated with meshed autograft. Donor site size (ASCS and STSG) was 225 sq cm (IQR:72,315), and ratio of donor site are to total treatment area was 0.0125 (IQR:0.01,0.32), suggesting an expansion of 80:1. Median LOS was 11 days (IQR:7,21), 0.84 days per %TBSA (IQR:0.5,1.16). Expected LOS was 14.3 days, with an O/E ratio of 0.77. Two patients developed infection; one required reoperation with STSG on half of his burned areas (5% TBSA). Conclusions Enzymatic debridement and ASCS can be used to treat burn injury with a “minimally invasive” approach. Donor sites were much smaller than expected had they been treated with a conventional meshed STSG on deep 2nd degree and 3rd degree areas. The data also suggests that length of stay was lower than expected. Further study is needed to determine which subsets of patients and burn wounds are optimal for this combination of technologies.
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- 2022
15. 92 ASCS Treatment Impact on Length of Stay Data and Costs for Patients with Small Burns
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Jeffrey E Carter, Joshua S Carson, Lisa Rae, Syed F Saquib, Lucy Wibbenmeyer, and William L Hickerson
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Introduction: Small burns with a total body surface area (TBSA) of < 20% account for the large majority (92%) of burn injury hospital admissions. Autologous skin cell suspension (ASCS) is a novel treatment for acute thermal burn injuries – including small burns -- that is associated with significantly lower donor skin requirements than split-thickness skin grafts, the traditional standard of care (SOC). The ASCS treatment indication was recently expanded from adult patients to include pediatric patients. Previously modeled analyses suggested that ASCS use is associated with a lower hospital length of stay (LOS) and costs savings versus SOC. This study evaluated whether real-world data (RWD) corroborate these findings in small burns and in both adult and pediatric populations. Methods Methods: Data were collected from January 2019 through August 2020 from 500 facilities in the United States. Adult patients (age ≥ 21) and pediatric patients (< age 21) receiving inpatient burn treatment with ASCS were identified and matched to patients receiving SOC based on sex, age, TBSA < 20%, and comorbidities. Based on typical BEACON model outcomes, LOS was assumed to account for 70% of total costs and was used as a proxy to assess the data. LOS was assumed to cost $7,554 per day. Mean LOS and costs were calculated for the ASCS and SOC adult and pediatric cohorts. The incremental revenue associated with changes in inpatient capacity was also analyzed. Results Results: A total of 151 ASCS and 2,243 SOC adult cases and 19 ASCS and 341 SOC pediatric cases were identified. In adults, the SOC cohort had a higher percentage of patients with TBSA < 20% than the ASCS cohort (82.9% vs. 55.0%). For small burns, sixty-three matches were made for each adult cohort, and seven matches were made for each pediatric cohort. For adults, LOS was 18.5 days with ASCS use and 20.6 days with SOC use (difference: 2.1 days [10.2%]). For pediatrics, the ASCS LOS was 18.6 days, and the SOC LOS was 21.4 days (difference: 2.9 days [15.4%]). This difference led to cost savings of $15,587.62 per adult ASCS patient. Total cost savings with ASCS adult patients were $22,268.03 per patient. The reduced LOS with ASCS adult patients resulted in an increased capacity of 2.0 inpatients per bed per year, which was estimated to increase hospital revenue by $83,894 per burn unit bed annually. Pediatric cost results and savings were similar. Conclusions Conclusion: This RWD analysis shows that small burn treatment with ASCS is associated with reduced LOS and substantial cost savings compared with SOC in both adult and pediatric populations, supporting the validity of previous model projections. ASCS use may also significantly increase hospital revenue related to increased inpatient capacity.
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- 2022
16. 813 Histologic Changes of Skin Biopsies After Autologous Skin Cell Suspension
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Shana Lennard, Jeffrey E Carter, Nicole M Kopari, Michael Cook, John Paige, Ian Hodgdon, Herb A Phelan, and William L Hickerson
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Over 10,000 cases of autologous skin cell suspension have been performed around the world for the treatment of burn and soft tissue injuries. A key component of the procedure is the harvest of skin biopsies which are exposed to enzymatic degradation. In some regions, epidermal graft harvest has been attempted manually without enzymatic degradation. Our study goal was to examine the histologic changes of the skin biopsies in manual versus enzymatic degradation. Methods Our study was an IRB-approved, prospective controlled analysis of residual skin harvested from 10 patients undergoing hernia repair. Two specimens from each patient were procured intraoperatively with each measuring 2x3cm. Each specimen produced two 4mm punch biopsies from three regions (control, mechanical, and enzymatic) for a total of 12 specimens per patient. Enzymatic specimens were prepared using the Avita Medical ReCell® system per manufacture instructions for use. Mechanical specimens were prepared using an abrasive pad until epidermis was macroscopically removed. Histologic analysis was performed with hematoxylin and eosin stain and whole slide scanning. Two or more investigators reviewed each biopsy concurrently with consensus agreement on the remaining epidermis and evidence of degraded reticular dermis. Descriptive statistics were used to assess the variances in the three groups. Results The mean residual epidermis was 9% in the enzymatic group, 35% in the mechanical, and 98% in the control. Epidermal harvest was higher in the enzymatic group relative to the mechanical group (two tailed t-test = 0.0008). Reticular dermis was degraded in 10% of the mechanical specimens and none of the enzymatic specimens. Conclusions Epidermal harvest was more consistent in the enzymatic group with less trauma to the dermis. Our study suggest that mechanical harvest requires larger donor sites given the decreased epidermal harvest. Further research is needed to determine impact of cell isolation technique on autograft cell suspension viability and distribution of cell types harvested.
- Published
- 2022
17. 504 Starting a Pediatric Burn Center: Challenges Faced in an Underserved Patient Population
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Nicole M Kopari, Jessica A Zagory, Kristen Lindsey, Herb A Phelan, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Burn injury is the third most common cause of childhood injury resulting in death. The CDC recognizing the South as having the highest rate of pediatric burn deaths in the U.S. Unfortunately, 10% of all child abuse cases involve burn injuries and 20% of all pediatric burn admissions are due to nonaccidental trauma. Our study demonstrated that aftercare was a major challenge in starting a pediatric burn center. We analyzed the rate of lost to follow-up in burn-injured children following surgery and our steps to address this need in our community through key partnerships within our state. Methods Our study is a single center review of pediatric burn-injured children undergoing surgery from 01/01/2021 through 09/30/2021. Lost to follow-up was defined as three or more consecutive months without clinic or telemedicine visits despite three of more documented communication attempts by attending surgeons and/or clinic staff. Children requiring child protective services (CPS) for suspected nonaccidental trauma were compared to those where nonaccidental trauma was not suspected. All children sustained burn injuries of sufficient severity to require excision and autograft with follow-up in the outpatient clinic. Families were provided with an after-visit summary reviewing the clinic appointment, transportation and meal assistance, and they received a call prior to clinic to remind them of the scheduled appointment. Results A total of 35 children required surgery with outpatient follow-up per protocol. 23% of the patients required CPS investigations. We reviewed 151 subsequent clinic visits and the associated cancellations, rescheduled appointments, and no-show visits. Children under the care of CPS had a higher rate of being lost to follow-up (50%) compared to other children (17%). Parents undergoing CPS investigation were 4x less likely to provide cancellation notice. Children placed in foster care had no cancellations, reschedules appointments, or missed visits despite a higher number of clinic visits overall. Conclusions Children suffering nonaccidental injuries represent an exceptionally vulnerable portion of our population. Burn injuries often are a public and personal reminder of severe trauma. CPS works to find a balance in securing a safe home while attempting to maintain a family unit. Our work demonstrated an unacceptably high rate of loss to follow-up for children requiring surgical intervention after injury especially in those with concerns for nonaccidental etiologies. As a result, our burn surgeons led an initiative with statewide burn directors and our state’s emergency response network to engage the state’s CPS department. Our goal was to raise awareness and increase education for CPS social workers and foster families on burn injury and aftercare needs.
- Published
- 2022
18. 86 Outcomes for 43 Hand Burns Treated with 2:1 Meshed and Epidermal Autografts with Abundant Donors
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Daniel Yoo, Malcolm M Taylor IV, Scott Barnett, Charles T Tuggle, Nicole Kopari, Jeffrey E Carter, and Herb A Phelan
- Subjects
Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Our group has previously reported our experience in treating hand burns with 2:1 meshed autografting and simultaneous application of autologous skin cell suspension (ASCS) even when donor sites are abundant. Here, we sought to expand on this experience. We hypothesized that the use of 2:1 meshed autografting and ASCS (MA/ASCS) would provide comparable outcomes to hand burns treated with sheet graft. Methods A retrospective review was conducted of all subjects operated on for deep 2nd and 3rd degree hand burns at our ABA-verified burn center from April, 2018 to May, 2021. Exclusion criterion was a burn of >20% TBSA. The cohorts were those subjects treated with MA/ASCS versus those treated with split thickness sheet, pie-crust, or 1:1 meshed autograft alone (STAG). Outcomes included proportion returning to work (RTW), length of time for RTW, and time to wound closure. Mann-Whitney U test was used for comparisons of continuous variables, and Fishers Exact test for categorical variables. Values are reported as median and interquartile range. Results Sixty-eight subjects fit the study criteria (MA/ASCS n=43, STAG n=25). The MA/ASCS group was significantly older than the STAG cohort (45.5 yrs [32, 59.25] vs 35 [28, 45], p=0.013) with larger %TBSA burns overall (11.5% [7, 16.25] vs 2% [1, 3], p < 0.0001), and larger hand burns (186 cm2 [124.75, 330.5] vs 104 cm2 [56, 164], p=0.001). Comparable results were seen between MA/ASCS and STAG, respectively, for time to wound closure (8 days [7, 13] vs 8 [6, 14], p=0.48), proportion RTW (51% vs 64%, p=0.33), and days for RTW among those returning (38 [29.25, 62.75] vs 34.5 [20.75, 57], p=0.471). Fractional ablations were performed in 14% of the MA/ASCS group and 12% of the STAG group. Conclusions Despite being significantly older, having larger hand wounds, and larger overall wounds within the parameters of the study criteria, patients with 20% TBSA burns or smaller whose hand burns were treated with 2:1 mesh and ASCS overspray had comparable time to wound closure and return to work as subjects treated with 1:1, pie-crust, or sheet STAG.
- Published
- 2022
19. 725 Case Series: New Porcine Placental ECM for Burn Injuries
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David G'sell, Jeffrey E Carter, Nicole M Kopari, and William L Hickerson
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Human amniotic membrane (HAM) has been used as a biologic dressing for burn wounds since 1955 but limited due to availability, size, and processing costs. In 2021 a new porcine placental product was FDA-approved overcoming challenges with human-sourced products. Our study is the first case series to report outcomes using porcine placental extracellular matrix (PPECM) in the use of adult burn patients. Methods Adults with thermal burns resulting in partial-thickness burn wounds (PTBW) were consented and included in the study from 03/2021 to 09/2021. Patients with full-thickness injures, concomitant trauma, or adverse beliefs to porcine products were not included in the study. Serial still images and initial wound measurements were obtained intraoperatively and post-operatively. PPECM trial product processed with a proprietary decellularization method to produce single sheets up to 15x20cm was approved by the facility value assessment committee. Adverse events were defined a priori as infection, increased pain or itching relative to adjacent autografts, or failure to heal. Infection was defined as a PPECM treatment site requiring any change from standard of care or initiation of local or systemic antibiotics. Pain was assessed using a visual analogue scale. Itching was assessed at discharge and follow-up. Healing was assessed using the FDA guidance for wound closure with 2 consecutive visits 2 weeks apart demonstrating 100% epithelialization without drainage or dressing requirements. Results Four patients were treated during the study period with wounds involving the torso and major joints such as the hands/wrists and knees. None of the PPECM wounds demonstrated failure to heal or required revision excision, or autograft. None of the PPECM wounds had evidence of infection. PPECM wounds had decreased pain/itching relative to adjacent burn wounds which were treated with split-thickness autograft, autologous skin cell suspension, or allogeneic cultured skin substitute (VAS mean 1 vs 3.1). Healing was noted in all wounds at 1-week primary dressing removal with confirmation at 2-week interval follow-up. Conclusions PPECM treatment of PTBW was not associated with adverse events and resulted in favorable outcomes clinically. The large size, ease of use, and lower costs relative to HAM is an intriguing alternative for PTBW. Comparative studies are needed in the field to determine best practices and overall value.
- Published
- 2022
20. Use of 816 Consecutive Burn Wound Biopsies to Inform a Histologic Algorithm for Burn Depth Categorization
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James H. Holmes, Jeffrey E Carter, Herb A Phelan, Clay J Cockerell, Jeffrey W. Shupp, and William L. Hickerson
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Clinical team ,Adnexal structures ,Male ,Wound Healing ,Burn wound ,Burn depth ,medicine.diagnostic_test ,business.industry ,Papillary dermis ,Rehabilitation ,Multicenter study ,Epidermal Cells ,Biopsy ,Emergency Medicine ,Medicine ,Humans ,Surgery ,Female ,Prospective Studies ,business ,Burns ,Reticular Dermis ,Algorithm ,Algorithms ,Skin - Abstract
Burn experts are only 77% accurate when subjectively assessing burn depth, leaving almost a quarter of patients to undergo unnecessary surgery or conversely suffer a delay in treatment. To aid clinicians in burn depth assessment (BDA), new technologies are being studied with machine learning algorithms calibrated to histologic standards. Our group has iteratively created a theoretical burn biopsy algorithm (BBA) based on histologic analysis, and subsequently informed it with the largest burn wound biopsy repository in the literature. Here, we sought to report that process. This was an IRB-approved, prospective, multicenter study. A BBA was created a priori and refined in an iterative manner. Patients with burn wounds assessed by burn experts as requiring excision and autograft underwent 4 mm biopsies procured every 25 cm2. Serial still photos were obtained at enrollment and at excision intraoperatively. Burn biopsies were histologically assessed for presence/absence of epidermis, papillary dermis, reticular dermis, and proportion of necrotic adnexal structures by a dermatopathologist using H&E with whole slide scanning. First degree and superficial second degree were considered to be burn wounds likely to have healed without surgery, while deep second- and third-degree burns were considered unlikely to heal by 21 days. Biopsy pathology results were correlated with still photos by five burn experts for consensus of final burn depth diagnosis. Sixty-six subjects were enrolled with 117 wounds and 816 biopsies. The BBA was used to categorize subjects’ wounds into four categories: 7% of burns were categorized as first degree, 13% as superficial second degree, 43% as deep second degree, and 37% as third degree. Therefore, 20% of burn wounds were incorrectly judged as needing excision and grafting by the clinical team as per the BBA. As H&E is unable to assess the viability of papillary and reticular dermis, with time our team came to appreciate the greater importance of adnexal structure necrosis over dermal appearance in assessing healing potential. Our study demonstrates that a BBA with objective histologic criteria can be used to categorize BDA with clinical misclassification rates consistent with past literature. This study serves as the largest analysis of burn biopsies by modern day burn experts and the first to define histologic parameters for BDA.
- Published
- 2021
21. Outcomes for Hand Burns Treated With Autologous Skin Cell Suspension in 20% TBSA and Smaller Injuries
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George Malcolm Taylor, Herb A Phelan, Scott A. Barnett, Charles T Tuggle, and Jeffrey E Carter
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Adult ,Male ,medicine.medical_specialty ,Soft Tissue Injuries ,Adolescent ,Transplantation, Autologous ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Suspensions ,Interquartile range ,Medicine ,Humans ,Retrospective Studies ,Body surface area ,Skin, Artificial ,Wound Healing ,business.industry ,Rehabilitation ,Hand Injuries ,030208 emergency & critical care medicine ,Burn center ,Skin Transplantation ,Middle Aged ,Surgery ,Exact test ,Surgical mesh ,Treatment Outcome ,Skin cell ,Cohort ,Emergency Medicine ,Mann–Whitney U test ,business ,Burns - Abstract
In order to address the confounder of TBSA on burn outcomes, we sought to analyze our experience with the use of autologous skin cell suspensions (ASCS) in a cohort of subjects with hand burns whose TBSA totaled 20% or less. We hypothesized that the use of ASCS in conjunction with 2:1 meshed autograft for the treatment of hand burn injuries would provide comparable outcomes to hand burns treated with sheet or minimally meshed autograft alone. A retrospective review was conducted for all deep partial and full-thickness hand burns treated with split-thickness autograft (STAG) at our urban verified burn center between April 2018 and September 2020. The exclusion criterion was a TBSA greater than 20%. The cohorts were those subjects treated with ASCS in combination with STAG (ASCS(+)) vs those treated with STAG alone (ASCS(−)). All ASCS(+) subjects were treated with 2:1 meshed STAG and ASCS overspray while all ASCS(−) subjects had 1:1, piecrust, or unmeshed sheet graft alone. Outcomes measured included demographics, time to wound closure, proportion returning to work (RTW), and length of time to RTW. Mann–Whitney U test was used for comparisons of continuous variables and Fisher’s exact test for categorical variables. Values are reported as medians and 25th and 75th interquartile ranges. Fifty-one subjects fit the study criteria (ASCS(+) n = 31, ASCS(−) n = 20). The ASCS(+) group was significantly older than the ASCS(−) cohort (44 [32–54] vs 32 years [27.5–37], P = .009) with larger %TBSA burns (15% [9.5–17] vs 2% [1–4], P < .0001) and larger size hand burns (190 [120–349.5] vs 126 cm2 [73.5–182], P = .015). Comparable results were seen between ASCS(+) and ASCS(−), respectively, for time to wound closure (9 [7–13] vs 11.5 days [6.75–14], P = .63), proportion RTW (61% vs 70%, P = .56), and days for RTW among those returning (35 [28.5–57] vs 33 [20.25–59], P = .52). The ASCS(+) group had two graft infections with no reoperations, while ASCS(−) had one infection with one reoperation. No subjects in either group had a dermal substitute placed. Despite being significantly older, having larger hand wounds, and larger overall wounds within the parameters of the study criteria, patients with 20% TBSA burns or smaller whose hand burns were treated with 2:1 mesh and ASCS overspray had comparable time to wound closure, proportion of RTW, and time to return to work as subjects treated with 1:1 or piecrust meshed STAG. Our group plans to follow this work with scar assessments for a more granular picture of pliability and reconstructive needs.
- Published
- 2021
22. The Golden Opportunity: Multidisciplinary Simulation Training Improves Trauma Team Efficiency
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Michael C. Chang, David A. Masneri, Andrea M. Long, Nathan T. Mowery, Jeffrey E Carter, Cedric M. Lefebvre, and James E. Johnson
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Male ,medicine.medical_specialty ,Resuscitation ,Time Factors ,education ,Time-to-Treatment ,Education ,Simulation training ,03 medical and health sciences ,0302 clinical medicine ,Trauma Centers ,Multidisciplinary approach ,medicine ,Humans ,Trauma team ,Hospital Mortality ,030212 general & internal medicine ,Simulation Training ,Patient Care Team ,Trauma Severity Indices ,business.industry ,Debriefing ,Emergency department ,Quality Improvement ,Cardiopulmonary Resuscitation ,Patient Simulation ,Treatment Outcome ,030220 oncology & carcinogenesis ,Emergency medicine ,Golden hour (medicine) ,Female ,Interdisciplinary Communication ,Surgery ,Clinical Competence ,business ,Trauma surgery - Abstract
Every trauma patient has a golden hour, and resuscitation efficiency within that hour has large implications for patients. We instituted simulation based trauma resuscitation training with the hypothesis that it would improve trauma team efficiency.Five simulation training sessions were conducted with immediate debriefing. Metrics collected in actual trauma resuscitations before and after simulation training included time of primary and secondary surveys and time to computed tomography (CT) scan. Study participants were from multidisciplinary specialties involved in trauma resuscitations as well as former trauma patients from the Trauma Survivors Network.Seventy-three patients undergoing trauma resuscitations were screened and 67 patients were included. Time to CT scan and secondary survey completion were significantly reduced in actual trauma patient activations following implementation of the curriculum (reduction of 23 to 16 minutes for CT scan p0.05, and reduction from 14 to 6 minutes for secondary survey, p0.05). Time to primary survey completion did not change (5 minutes).Multidisciplinary simulation training was associated with improved trauma team efficiency in the form of reduced assessment time. As emergency department length of stay is an independent predictor of hospital mortality following trauma activation, team-based simulation training has the potential to improve patient outcomes. Multidisciplinary involvement was a key factor, and Trauma Survivors Network involvement brought credibility from the patient perspective.
- Published
- 2019
23. Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries
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Kevin N Foster, Bruce A. Cairns, J H Holmes, Booker T. King, Jeffrey E Carter, Jeffrey W. Shupp, Joseph A. Molnar, and William L. Hickerson
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Autologous cell ,medicine.medical_specialty ,Control treatment ,Standard of care ,integumentary system ,business.industry ,medicine.medical_treatment ,030208 emergency & critical care medicine ,General Medicine ,Critical Care and Intensive Care Medicine ,Surgery ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Emergency Medicine ,medicine ,Wound closure ,business ,Reduction (orthopedic surgery) ,Donor skin - Abstract
Introduction Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL® Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient’s skin to treat up to 80 cm2 of excised burn. Methods A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. Results At 8 weeks, 85% of the Control-treated wounds were healed compared with 92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32% with the use of RECELL (p Conclusions In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.
- Published
- 2019
24. Remission of Pain From Frostbite and Erythromelalgia With Epidural Infusion of Ropivacaine: Results of a Two-Year Follow-Up
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Jeffrey E Carter, Joseph D. Giaimo, Kelly L Paulk, Herbert Phelan, Frank H. Lau, and Elizabeth B Grieshaber
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business.industry ,Ropivacaine ,Erythromelalgia ,Anesthesia ,Frostbite ,MEDLINE ,Medicine ,General Medicine ,business ,medicine.disease ,medicine.drug - Published
- 2020
25. 607 Use of Autologous Skin Cell Suspension (ASCS) for Full-thickness Burn Injuries Reduces Autograft Procedures
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James H Holmes, Kevin N Foster, Booker King, Rajiv Sood, Jeffrey E Carter, and William L Hickerson
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Pediatric burn patients and patients with large TBSA injuries are vulnerable to morbidity and mortality, requiring multiple autograft (AG) procedures to obtain definitive closure due to limited donor site availability. The primary objective of this study was to understand the impact of ASCS, as an AG-sparing technology, on the number of AG procedures required to achieve definitive closure of full-thickness (FT) acute thermal burns. Methods Retrospective analyses of real-world data were conducted, evaluating clinical outcomes of ASCS-treated patients in prospective, uncontrolled observational studies compared to control data from patients in the National Burn Repository version 8.0 (NBR) who had conventional AG (SOC). The pediatric population consisted of patients < 18 years of age, inclusive of any size TBSA, and the adult cohort included patients ≥ 18 years of age with >50% TBSA injury. Propensity score stratification was used to reduce bias attributable to potential differences in age, sex, %TBSA, and Baux scores between nonrandomized cohorts. Clinical outcomes evaluated included number of AG treatments, length of stay (LOS), healing, and mortality. Additional adverse events were evaluated and compared to historical SOC data sets. Results The median number of AG procedures for pediatric patients treated with ASCS and control NBR cohorts was 1.0 (1.0-5.0) and 2.0 (1.0-20.0), respectively. For adult patients, the ASCS-treated and NBR cohorts had medians of 2.0 (1.0-6.0) and 5.0 (1.0-32.0) treatments, respectively. Overall, ASCS lead to approximately 60% fewer mean AG procedures for both populations. By week 8, re-epithelialization was observed in 91.8% and 90.6% of wounds in the pediatric and adult ASCS-treated cohorts. Median LOS for both cohorts were not different between the treatment groups. No significant differences were observed for mortality between cohorts and no adverse events attributed to ASCS were reported. Conclusions ASCS treatment reduced the number of AG procedures needed to achieve closure, benefiting patients and offering burn centers reduced complexity and cost in the patient care pathway. While LOS was not significantly reduced in this study as seen in other reports, this finding may be confounded due to potential differences in the patient cohorts relative comorbidities and polytrauma, as well as variability in clinical site inpatient/outpatient management strategies for OT/PT.
- Published
- 2022
26. 538 Partial Thickness Pediatric Burn Injuries Treated with Autologous Skin Cell Suspension
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Nicole M Kopari, Fabienne Gray, Herb A Phelan, and Jeffrey E Carter
- Subjects
Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Management of pediatric burn injuries resulting in optimal aesthetic remains a significant challenge in burn care. Wound care and acute surgical intervention coupled with reconstructive interventions is an essential component of burn care. Incorporation of new technologies in burn care has challenged historic paradigms. Our goal was to evaluate the use of autologous skin cell suspension (ASCS) for the treatment of partial-thickness pediatric burn injuries. Methods A retrospective chart review from a single pediatric institution over a 10-month period was performed on patients undergoing treatment with ASCS. Patients with full-thickness injuries treated with autografting were excluded. Demographics and data collection included total burn surface area (TBSA), location of burn, mechanism of burn, time to ASCS application, time to >90% re-epithelization, hospital length of stay, ASCS failure requiring repeat operation, and reconstructive procedures or laser interventions. Results 26 pediatric patients ≤13 years of age charts were reviewed. 14 patients received ASCS and met inclusion criteria. 8 faces were included in our study along with 11 upper extremity burns, 5 lower extremity burns, and 8 torso burns or some combination of the above. The most common etiology was scald injury from hot water followed by noodle soup burns and grease burns. Other etiologies included road rash, flame burn, and a steam burn. ASCS was applied 2 days (range 1-4) after injuries and patients only required 1 operation. The average length of hospital stay was 4 days (range 1-10) and the average TBSA was 10% (range 4-17). The average time to >90% re-epithelization was 7 days with one outlier with healing at day 24. This is the only patient in the ASCS group that required laser interventions. No patients required repeat procedures, subsequent autografting, or reconstructive procedures. Conclusions Pediatric patients with partial-thickness burns benefitted from the ASCS by having limited donor sites, short hospitalizations compared to %TBSA, improved time to >90% re-epithelization, and no repeat surgical interventions. The fast-healing time and good cosmetic outcome decreases the need for compression garments and subsequent laser interventions. Key factors include patient selection and appropriate wound preparation.
- Published
- 2022
27. 55 Initial Experience Using Artificial Intelligence for the Assessment of Pediatric Burn Depth
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James H Holmes, Herb A Phelan, Jeffrey W Shupp, J Michael DiMaio, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Estimation of burn depth, and hence severity, is critical for burn management. Burn depth estimates vary widely, and these inaccuracies can be compounded in pediatric burns. A reliable, objective, non-invasive device for the accurate assessment of burn depth is needed. A non-invasive imaging technology, using multispectral imaging (MSI) combined with a machine learning algorithm (MLA), is being developed as a tool for burn depth assessment. The results of the initial multi-center study using this artificial intelligence (AI) technology in pediatric burns are presented. Methods The MSI device was used to image subjects < 18y of age with thermal burns < 50% TBSA. It captured a set of images measuring the reflectance of visible and near-IR light, within a 23x23 cm field-of-view. Images were collected from up to 2 separate burned regions within 72 hours of injury that were then serially imaged for up to 7d post-injury. Burns that the investigator believed would heal spontaneously (superficial or superficial partial-thickness) were managed per institutional standard of care (SOC) and assessed at 21d post-injury for complete healing. Burns that the investigator felt would not heal by 21d post-injury (deep partial-thickness or full-thickness) were excised and grafted per institutional SOC, with multiple biopsies being taken prior to excision. Regions of non-healing burn within every MSI image were identified by a panel of 3 burn surgeons. To accurately identify these non-healing regions, the panel of surgeons was given access to 1 of 2 clinical reference standards: a) the 21-day healing assessments for burns allowed to heal spontaneously; or b) pathology reports detailing histologic analyses from the biopsies. This information was then used to develop a type of MLA called a convolutional neural network (CNN) that could automatically identify the regions of non-healing burn within an image. From these data, an ensemble of 8 separate CNN algorithms was used to automatically identify non-healing burn tissue. Training and test accuracies of the ensemble CNN were calculated using cross-validation at the level of the subject. Results Twenty-four (24) pediatric burn patients were enrolled, with 26 burned areas being serially imaged. The age range of the subjects was 7 months - 17y, with a mean age of 5.7y. Subjects had a mean burn size of 8.0 ± 4.2% TBSA, and 70% of the subjects were male. The AI performance results showed an accuracy of 88.2 ± 3.7%, sensitivity of 80.0 ± 14.6%, specificity of 88.0% ± 3.7%, and an area under the curve (AUC) of 0.92. Conclusions Our study demonstrates an improvement in the accuracy of burn depth assessment over the traditional exam, which could lead to improved burn care.
- Published
- 2022
28. 13 Statewide Prehospital Routing of Burn Injuries Reduces Patient Length of Stay
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Randy D Kearns, Tracee Short, Joseph Barrios, Kevin Sittig, Paige B Hargrove, Chris W Hector, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction In the U.S., traumatic injuries are the leading cause of death before age 45 and have a significantly lower mortality if routed to a verified trauma center. Burn injuries are included in trauma statistics and represent 1.1 million injured people annually seeking medical assistance. Routing of burn injuries to ABA-recognized burn centers has yet to be assessed as it has in trauma injury. Our goal was to examine the impact of prehospital routing of burn injuries on hospital length of stay, mortality, and potential costs of care through a statewide care coordination center, the Louisiana Emergency Response Network. Methods Our study is a retrospective statewide analysis of burn injuries from 01/01/2017 thru 12/31/2019 using the Louisiana Hospital Inpatient Discharge Database. Routing of burn patients was implemented in 2018 using the ABA burn referral criteria. Data included: total admissions with primary burn diagnosis, region, discharge status, length of stay, and raw mortality by region and state. Descriptive and comparative statistics were performed to assess the impact of routing of burn injured patients. Cost analysis was performed using Louisiana Medicaid per diem rates from 2021 at $1,907.92/day. Results 1,288 patients were treated in Louisiana during the study period with 855 post-routing and 433 pre-routing. The mean length of stay was reduced from 11.84 days in 2017 to 8.82 days in 2018 (p value=0.0988) with a potential savings of 761 inpatient care days or $2.17 million. Overall mortality across the state was unchanged except in the highest volume region where it dropped from 7.9% in 2017 to 3.6% in 2019 (54%). Conclusions Burn injuries meeting ABA referral criteria are a form of time-sensitive trauma. This study marks the first analysis pre and post implementation of routing for burn injuries by a statewide care coordination center. Our study demonstrates improvement in length of stay and mortality but a continued need to examine other contributing factors such as severity of injury and concomitant trauma.
- Published
- 2022
29. 544 Southern US Burn Centers, Surge Capacity and 15 Months of the COVID19 Pandemic
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Randy D Kearns, Carl A Flores, William L Hickerson, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Burn mass casualty incident (BMCI) planning efforts have been in practice and publication for 40+ years. Through these ongoing efforts, we know there are measurable limits to burn center capacity and capability through modeling and real-world events relying on conventional and contingency standards of care, even when the only focus is those patients with burn injuries. The southern region of the American Burn Association (ABA) includes 37 burn centers and continues to play a critical role in the BMCI preparedness process. COVID-19 has emerged as the greatest pandemic in terms of morbidity and mortality since the 1918 influenza pandemic. While COVID-19 has no direct connection to burn injuries, the impact of COVID-19 on the American Healthcare System to include burn care was and remains significant. Methods We conducted a retrospective analysis of (southern) regional data voluntarily submitted to the ABA from March 2020 to June 2021 and generally coincides with the first three waves of the pandemic. We focused on the self-reported data specific to the three critical components in managing a surge of patients: staffing, space, and supplies (to include pharmaceuticals and equipment). Results Staff: These data were collected over a period that coincided with the first three waves seen in the region. Staffing shortages were noted during each of the surges but were most excessive when a regional surge paralleled surges in other parts of the country (November-December 2020). Space Late November and early December 2020, space was in short supply with the surge of patients for more of the region than at any other time during the 28 weeks of reporting. While single facilities reported other episodes of limited space or supplemented with temporary structures, the peak was early December. Supplies As the first surge began to subside, the supply shortages were abated. However, as additional surges occurred, the supply chain had not recovered. Supply shortages were reported in greater numbers than either space or staffing needs through the multiple waves of the pandemic. Conclusions The surge of patients that had to be managed by the greater healthcare community placed a substantial strain on the burn centers to keep beds dedicated for patients with burn injuries. The pandemic directly led to a diminished available capacity for burn care in such a way that it could have compromised our ability to confront a surge of burn-injured patients. Future BMCI planning efforts must consider this aspect of the process. Crisis Standards of Care may come into play during such an event.
- Published
- 2022
30. 596 Implementation of a Burn Laser Program at a Children’s Hospital
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Nicole M Kopari, Kristen Lindsey, Herb A Phelan, and Jeffrey E Carter
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Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Carbon dioxide ablative fractional laser (CO2-AFL) therapy has become standard of care for adult burn hypertrophic scars (HTS). This therapy option has not been widely adopted in pediatric burn care and no established guidelines for treatment protocols have been published. We sought to modify our American Burn Associated Adult Verified Burn Centers laser protocol at our Children’s Hospital with hopes to provide optimal care to our pediatric burn population. We present our protocol and early experience of CO2-AFL therapy for pediatric burn HTS. Methods We conducted a retrospective chart review of pediatric burn patients undergoing CO2-AFL treatment of HTS during the study period of Jan 2021-Oct 2021. Pediatric burn patients were offered laser treatment if their scars were symptomatic with patient complaints of HTS, pruritis, neuropathic pain, and scar contractures. 37 pediatric patients ≤13 years of age were included in our review. Results We treated 13 pediatric patients for a total of 40 laser sessions with each patient averaging 3 sessions. Of the 13 patients that were treated with laser, 62% (8 of the 13 patients) had split-thickness skin grafting with 38% (3 of the 8 patients) of those having a staged grafting procedure with dermal substitute. 15% (2 of the 13 patients) healed primarily and 15% (2 of the 13 patients) required excision and closure. Only 1 patient treated with ASCS alone required laser therapy. Our protocol requires patients to receive pre-operative Tylenol, Benadryl, Pepcid, and Oxycodone. The patients then received MAC anesthesia with Toradol, Dexamethasone, Ketamine or Propofol, and Zofran. Patients with extensive HTS on the face or neck were intubated for the procedures. Oxycodone and/or Dilaudid were provided if needed in the post-operative phase. All patients were discharged with Tylenol or Motrin and Triamcinolone 0.1% ointment to be applied daily for 48 hours and then 3-4x/day until the follow-up clinic appointment at one week. Patients were able to resume normal activities the day following the procedure. Conclusions Patients and their parents have reported improvements in pigment, pliability, thickness, and pruritis following laser treatments. We created a protocol that allows on average 8 pediatric patients per day to receive laser treatment without it over burdening the pre-operative and post-operative recovery room nursing staff. We are currently tracking outliers of patients requiring increased post-operative analgesia and/or greater than 1 hour in the recovery phase. With the implementation of a laser protocol, we have successfully introduced laser therapy as a viable option for our pediatric burn survivors.
- Published
- 2022
31. Enhancement of Diaminobenzidine Colorimetric Signal in Immunoblotting
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Laurie A. Pukac, Jeffrey E. Carter, Kenneth S. Morrison, and Morris J. Karnovsky
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Biology (General) ,QH301-705.5 - Published
- 1997
- Full Text
- View/download PDF
32. Prevention of Drug and Substance Use Among Young People
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Jeffrey E. Carter and Jeffrey E. Carter
- Subjects
- Youth--Substance use--Prevention, Youth--Drug use--Prevention
- Abstract
In popular culture, the American college experience almost always includes drug or alcohol abuse as a rite of passage. However, despite the widespread use of alcohol and drugs in movies and television shows set on college campuses, these media reinforce a false narrative, especially when it comes to drug use. While nearly 75% of college students report using alcohol at least once during high school, drug use among college students tends to begin during college. Chapter 1 provides information on preventing substance use among college students. A recent report found that in 2019, approximately 2.2 million youth ages 12 to 17 used illicit drugs, including marijuana, in the past 30 days. This substance use can lead to a variety of problems that can cause use to escalate to a substance use disorder and put children, adolescents, and young adults at risk for other related health consequences. Chapter 2 offers information that can help reduce the risks of substance use. Chapter 3 explains counterfeit pills.
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- 2023
33. A Comparative Study of the ReCell® Device and Autologous Split-Thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
- Author
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Bruce A. Cairns, Joseph A. Molnar, Marion H. Jordan, Sharmila Dissanaike, James Hwang, Rajiv Sood, Tina L Palmieri, David G. Greenhalgh, William L. Hickerson, Michael J. Feldman, C. Wayne Cruse, David W. Mozingo, Michael Peck, Jeffrey E Carter, Kevin N Foster, David J. Smith, J H Holmes, Booker T. King, and John A. Griswold
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Clinical Sciences ,Original Articles: ABA Papers ,Site size ,Transplantation, Autologous ,law.invention ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Standard care ,Randomized controlled trial ,law ,Medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Transplantation ,Wound Healing ,business.industry ,Rehabilitation ,030208 emergency & critical care medicine ,Skin Transplantation ,Middle Aged ,Surgical Mesh ,Emergency & Critical Care Medicine ,Surgery ,Surgical mesh ,Treatment Outcome ,Emergency Medicine ,Tissue and Organ Harvesting ,Female ,business ,Wound healing ,Burns ,Autologous ,Donor skin - Abstract
Early excision and autografting are standard care for deeper burns. However, donor sites are a source of significant morbidity. To address this, the ReCell® Autologous Cell Harvesting Device (ReCell) was designed for use at the point-of-care to prepare a noncultured, autologous skin cell suspension (ASCS) capable of epidermal regeneration using minimal donor skin. A prospective study was conducted to evaluate the clinical performance of ReCell vs meshed split-thickness skin grafts (STSG, Control) for the treatment of deep partial-thickness burns. Effectiveness measures were assessed to 1 year for both ASCS and Control treatment sites and donor sites, including the incidence of healing, scarring, and pain. At 4 weeks, 98% of the ASCS-treated sites were healed compared with 100% of the Controls. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Significant differences were observed between ReCell and Control donor sites. The mean ReCell donor area was approximately 40 times smaller than that of the Control (P < .0001), and after 1 week, significantly more ReCell donor sites were healed than Controls (P = .04). Over the first 16 weeks, patients reported significantly less pain at the ReCell donor sites compared with Controls (P ≤ .05 at each time point). Long-term patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. This study provides evidence that the treatment of deep partial-thickness burns with ASCS results in comparable healing, with significantly reduced donor site size and pain and improved appearance relative to STSG.
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- 2018
34. Supervisor, Colleague, or Assistant: General Surgery Resident Perceptions of Advanced Practitioners
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John Migaly, Leah M. Sieren, Jeffrey E Carter, Amy N. Hildreth, Clancy J. Clark, and John H. Stewart
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medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,Resident training ,General surgery ,ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS ,MEDLINE ,Workload ,Resident education ,General Medicine ,030230 surgery ,Process of care ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Perception ,Medicine ,Topic areas ,business ,Residency training ,media_common - Abstract
Integration of advanced practitioners (APs) into academic medical centers can improve processes of care and decrease physician workload but may adversely impact general surgery residency training. The aim of the present study was to characterize general surgery resident perceptions of APs and their impact on resident training. We conducted an institutional review board–approved survey covering five topic areas: knowledge of AP training, interaction with APs, scope-of-practice of APs, role of APs in the health-care team, and impact of APs on physician training. The survey was administered to general surgery residents at six large academic medical centers. One hundred eighteen general surgery residents completed the survey. The majority (43.6%) of respondents were junior residents. All respondents had interactions with APs with 90.7 per cent having worked directly with an AP in the last month. Residents reported minimal formal educational involvement by APs with 6.8 per cent reporting participation in didactics and 22.2 per cent teaching operative techniques. Almost half (44.1%) of the respondents reported that APs played an important role in their education, and 42.4 per cent of respondents disagreed or strongly disagreed that the role of the AP is well defined in their hospital. Today's general surgery residents work closely with APs who seem to positively impact resident education. Although residents perceive significant benefit with integration of APs, well-defined roles are lacking.
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- 2018
35. Pediatric erythromelalgia treated with epidural ropivacaine infusion
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Brian Ball, Jeffrey E Carter, Elizabeth Grieshaber, Caroline E. Lee, Kristen Garvie, and Kelly Paulk
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business.industry ,Ropivacaine ,MEDLINE ,Case Report ,Dermatology ,medicine.disease ,epidural ropivacaine ,erythromelalgia ,pediatric dermatology ,Erythromelalgia ,Anesthesia ,Medicine ,Pediatric dermatology ,business ,medicine.drug - Published
- 2019
36. 578 Failure to Follow-Up: Implementation of a Program to Reduce Risk and Engage Patients
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Sydney Smith, Lacy Virgadamo, Jeffrey E Carter, Herbert Phelan, David G’Sell, Mario Rivera-Barbosa, and Kathryn Mai
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business.industry ,Rehabilitation ,Emergency Medicine ,Medicine ,Surgery ,Medical emergency ,business ,medicine.disease - Abstract
Introduction Establishing a patient-physician relationship creates a duty to meet the standard of care for inpatients and outpatients. Growth in burn ambulatory care, workforce changes, and the digital age of healthcare communications have broadened the definition of the patient-physician relationship and increased ambulatory medical liability especially when patients fail to follow-up (FTF). To mitigate this risk, many professional liability insurers have advised physician practices to implement processes to ensure appropriate follow-up and communication. Our study reviewed a multidisciplinary quality and performance improvement initiative to reduce risk from FTF with a goal to improve patient engagement. Methods In response to notification by our medical professional liability insurer, a multidisciplinary team of burn specialists reviewed, designed, and implemented a FTF risk reduction program at an ABA-verified burn center. Burn surgeons, physician assistants (PA), nurses, schedulers, and administrative assistants contributed to the development of the FTF protocol. Patients were discharged with follow-up date and time from inpatients stays or at the conclusion of outpatient encounters. If a patient had a FTF event, three attempts were made to contact the patient starting with the scheduler, followed by the nurse, and finally the PA or MD. Each attempt was documented in the EMR. Compliance with the FTF protocol was monitored twice monthly as a component of the burn quality and performance improvement program. Outpatient encounters were abstracted from the EMR into three categories: completions, cancellations, and FTF over a 4-month period prior to implementation and 4-month period post implementation. Results Our analysis included over 2,678 outpatient physician/PA encounters. Prior to implementation patients were intermittently contacted with no consistent processes or documentation in the EMR. Staff compliance with the FTF protocol improved from 83% the first month after implementation to 100% by the fourth month. Interestingly, the failure to cancellation rate remained stable while the failure to follow-up rate declined from 15% prior to implementation to 13% post implementation. Patients failing to follow-up commonly stated that they forgot or had transportation challenges. Conclusions FTF protocols are essential to engage patients and reduce ambulatory professional liability. Patients will continue to face FTF challenges with language barriers, transportation issues, natural disasters, and even the pandemic. This study was not designed to reduce cancellations or FTF as it is reactionary. Additional work is needed to reduce all causes of FTF and to improve outpatient engagement.
- Published
- 2021
37. 124 Autologous Skin Cell Suspension Achieves Closure of Donor Site Wounds Facilitating Early Re-harvesting for Large TBSA burn Injuries
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Rajiv Sood, Brett C. Hartman, Steven Kahn, Jeffrey E Carter, James H. Holmes, Kevin N Foster, Jeanne Lee, Joseph A. Molnar, Beretta C Coffman, and William L. Hickerson
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medicine.medical_specialty ,Skin cell ,business.industry ,Rehabilitation ,Emergency Medicine ,medicine ,Closure (topology) ,Surgery ,business ,Suspension (vehicle) - Abstract
Introduction Management of extensive burn injuries is complicated often resulting in significant morbidity and mortality. Current standard of care includes use of split-thickness skin grafts (STSG) to obtain definitive closure; however, this treatment is often limited by donor site availability, which requires repeated re-harvesting of donor sites to obtain definitive closure in large total body surface area injuries. Additionally, this limitation often leads to increased risk of infection, hypertrophic scarring, and extended hospital length of stay. Autologous skin cell suspension (ASCS) prepared using the autologous cell harvesting device is an FDA approved point-of-care regenerative medicine technology that significantly reduces donor skin requirements to achieve definitive closure in acute thermal burn injuries across small and large burns. A prospective uncontrolled observational study (IDE 15945—NCT02992249) was conducted in which patients with life-threatening burn injuries were treated with ASCS. In this study, clinical outcomes were evaluated when ASCS was used in combination with wide meshed autografts for burn site treatment. Within the study, a subset of donor sites was also treated with ASCS and the purpose of the current work was to evaluate the clinical outcomes obtained to better understand impact on healing times and effect of re-harvesting in this compromised patient population. Methods ASCS was applied to the donor site after harvesting of split-thickness skin grafts. Clinical outcomes out to one year were evaluated, including the percentage of re-epithelialization, long-term cosmetic outcomes, and adverse events. Results Subjects (n=96) from 22 burn centers received ASCS as part of their donor site treatment regimen (n=528). Mean subject baseline demographics were: 30.2 years of age, 54.0 ± 17.4% TBSA injury, and 89.4 ± 32.9 Baux score with 37% of subjects having a score greater than 100. Percentage of donor sites healed, defined as >95% re-epithelialization, was 37.1% and 82.7% after week 1 and week 2, respectively. Approximately 20% of the donor sites treated with ASCS were re-harvested multiple times following initial healing (up to four times). Of these donor sites 39.3% (n=84), 81.0% (n=79), and 85.7% (n=77) were healed by week 1, week 2, and week 4, respectively. Scar assessments conducted on 427 donor sites after one year showed the majority had matched or mildly mismatched color, pigment, and texture. Safety analyses of adverse events (AEs) following ASCS treatment were unlikely or unrelated to the device. Conclusions This study demonstrates successful use of ASCS to achieve closure of donor site wounds in patients with extensive burn injuries.
- Published
- 2021
38. 541 72 Facial Burns Treated with Autologous Skin Cell Suspension- A Real World Data Analysis Across 5 U.S. Burn Centers
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Steven Kahn, Nicole M Kopari, J K Bailey, Anju Saraswat, Jeffrey E Carter, Herbert Phelan, Joseph A. Molnar, and James H. Holmes
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medicine.medical_specialty ,Burn therapy ,business.industry ,Rehabilitation ,Thermal burn ,Surgery ,Transplantation ,Skin cell ,Emergency Medicine ,Medicine ,Wound closure ,business ,Suspension (vehicle) ,Real world data - Abstract
Introduction Optimal management of facial burn injuries remains a significant challenge in burn care. Acute surgical intervention is often coupled with delayed reconstructive procedures as an essential option for burn care. Experience with new surgical technologies could challenge historic reconstructive ladders. Our goal was to pragmatically assess the rate of successful intervention with autologous skin cell suspension (ASCS) for the treatment of facial burn injuries from real-world data. Methods A retrospective review from five burn centers over a three-year period was performed from deidentified registry data for facial burn injuries initially treated with ASCS. Cases of non-acute thermal burn and burns not involving the face were excluded. Data collection included: date of surgery, last follow-up date, need for grafting (split or full thickness skin graft, STSG or FTSG, respectively) or reapplication of ASCS within the same hospitalization, and reconstruction not including laser procedures due to scarring during the follow-up period. Descriptive statistics were calculated and data are reported as median with interquartile ranges where appropriate. Results A total of 72 burn injuries were treated with ASCS for facial burn injuries. Two burn centers treated 4 patients each, one treated 18, and the remaining two treated 22 and 24 patients. The median follow-up was 199 days (range 9 -1,150 days). Acute failure requiring a second treatment with ASCS or application of a full-thickness or split-thickness autograft occurred in 12 (16%) of the patients with 5 undergoing re-application of ASCS and 7 undergoing FTSG or STSG. reconstruction secondary to scarring during the follow-up period occurred in 10 (14%) of patients. Reconstruction was required in 1 of 5 patients that underwent a second treatment with ASCS as opposed to 4 of 5 patients treated with FTSG or STSG. Conclusions This study represents the largest experience with the use of ASCS for the management of facial burn injury in the reported literature. Use of ASCS from real-world data indicated that ASCS successfully resulted in definitive wound closure in 90% of the patients treated with facial burn injuries, with 10% requiring secondary intervention. This failure rate is below the previously published rate of 33%, indicating the disruptive potential of this technology for the management of facial burn injuries.
- Published
- 2021
39. 615 The Effects of the COVID-19 Pandemic on Implementation of a Psychological Distress Screening Program after Burn Injury
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Paul A. Nakonezny, Nathan H Brown, Jeffrey E Carter, and Herb A Phelan
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R-134 Psychological and Psychosocial ,education.field_of_study ,Burn injury ,medicine.medical_specialty ,AcademicSubjects/MED00910 ,business.industry ,Psychiatric assessment ,Rehabilitation ,Population ,Burn center ,Psychological and Psychosocial ,Mood ,Interquartile range ,Emergency medicine ,Emergency Medicine ,medicine ,Anxiety ,Surgery ,medicine.symptom ,education ,business ,Screening procedures - Abstract
Introduction The relationship between psychiatric conditions and burn injury is complex, as disorders in thought or mood can both predispose to as well as result from thermal injury. We sought to describe our center’s experience with implementation of a psychological distress screening program in the run-up to and during the COVID-19 pandemic. Methods We undertook an analysis of de-identified data as part of a quality improvement review focusing on the results of psychological screening of our outpatient burn population. In the spring of 2019, our verified burn center implemented an outpatient screening program consisting of a registered nurse administering three validated test to screen for Post-Traumatic Stress Disorder screen, depression and anxiety, and problematic alcohol consumption to all patients at the time of physically checking in for their first burn clinic appointment. All outpatients triggering a positive screen are subsequently referred to the burn unit PsyD while a negative screen results in monthly repeat screenings until discharge from the burn clinic or a positive screen, whichever comes first. We analyzed data from the last twelve months of normal outpatient workflow. Loess regression was used to analyze the monthly proportions of patients screening positive. Results During the peak of COVID-19 in our region, clinic staff were reduced, and screening procedures suspended for the months of March and April 2020. Therefore, the study period consisted of 01 July 2019 to 31 August 2020. A median of 36.5 screens were conducted per month [interquartile range 27.75, 44.75]. Of these screens, 26.5% were positive, with 94.2% successfully referred to the burn unit’s postdoctoral fellow. The Loess regression showed the proportion of patients screening positive for psychological stressors from July 2019 until a peak in November 2019. A downtrend was then noted in the proportion screening positive from December 2019 to date (Figure). Conclusions Psychological stressors are prevalent in burn outpatients. We attribute the decrease in positive responses beginning in December 2019 to a combination of a decrease in the frequency of repeat administrations of the screening test in patients after screening positive, and a reluctance of anxious patients to present to the burn clinic for fear of COVID exposure while at the facility.
- Published
- 2021
40. 539 If Seeing Was Believing - A Retrospective Analysis of Potential Reduced Treatment Delays with a Novel Burn Wound Assessment Device
- Author
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Herbert Phelan, Jeffrey E Carter, Henry B Huson, Sydney Smith, and David G’Sell
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medicine.medical_specialty ,Burn wound ,business.industry ,Rehabilitation ,Emergency medicine ,Emergency Medicine ,Retrospective analysis ,Medicine ,Surgery ,business - Abstract
Introduction Burn care (BC) remains a highly specialized and resource intensive specialty with only 2% of hospitals featuring a burn center and less than 1% of graduating general surgery and plastic surgery residents pursing a burn fellowship each year. Access to specialized care is further complicated by burn wound assessment (BWA) which is commonly performed visually without adjunctive devices. To help clinicians make more accurate assessments and potentially reduce delays in transfer or treatment, a new non-invasive imaging device for BWA is being developed using visible and non-visible wavelengths of light with machine learning algorithms. Our goal was to assess the potential reduced treatment delay (RTD) and associated financial savings by implementing such a device using our burn center’s historical data. Methods The study was an IRB-approved, retrospective review of admissions from 07/01/2018 through 06/30/2019. Inclusion criteria: thermal, chemical, contact, or electrical mechanism of injury, >15 years of age requiring excision, and length of stay >72 hours. Inclusion data included: presence/absence of concomitant trauma, day of surgery, day of admission, day of electronic order entry for case request, and length of stay per percent total body surface area (LOS%TBSA). RTD was defined starting >48 hours after injury daily until electronic order entry for surgical case request. Reduced costs were calculated per day from prior studies ranging $3,000 to $5,100/day. Results A total of 109 patients were included. 29 patients had case requests placed within 48 hours of admission. Of the remaining 80 patients, a potential of 398 days would have been saved had a novel BWA adjunctive imaging devices aided surgeon to requests earlier surgical intervention. Overall savings from reduced length of stay range from $1,194,000 to $2,029,800 dollars. Conclusions Our study demonstrates that should a BWA technology with accuracy 48 hours after injury be developed, even burn centers with 24-hour access to operating rooms can reduce treatment delays. The study does not look at additional cost savings offered by reduced emergent transfers or admissions which offer additional intrigue and promise.
- Published
- 2021
41. 622 Enhanced Recovery After Surgery for Fractional CO2 Laser Treatment of Burn Scars
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Lacy Virgadamo, Orlando Salinas, Jeffrey E Carter, Amy K Lavis, David G’Sell, Charles W Jastram, Sydney Smith, Kathryn Mai, and Herbert Phelan
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medicine.medical_specialty ,Co2 laser ,business.industry ,Rehabilitation ,Emergency Medicine ,medicine ,Surgery ,business ,Enhanced recovery after surgery ,Burn scar - Abstract
Introduction Healthcare systems have adopted enhanced recovery after surgery (ERAS) programs as evidence-based, multimodal, and multidisciplinary perioperative approaches to mitigate complications and improve early recovery. ERAS programs modify psychological and physiological response to surgery with standardized care pathways that range from preoperative assessment and education through pharmacologic and surgical interventions. Our study demonstrates a burn scar specific ERAS protocol with pre- and post- intervention outcomes. Methods As part of a quality and performance improvement initiative, a multidisciplinary panel at an ABA-verified burn center consisting of burn nurses, burn surgeons, burn physician assistants, burn therapist, clinical pharmacist, certified medical laser safety officer, and anesthesiologist reviewed the available literature regarding pain, laser treatments, and medication histories of prior fractional CO2 laser treatments. The ERAS program was designed with preoperative, perioperative, and postoperative interventions to reduce pain and complications defined as unscheduled visits/admission to the ER or burn center, narcotic administration >1 hour post procedure, or wound complications secondary to laser treatment requiring dressing changes >1 week post-procedure. Quality and performance metrics were collected as a component of the burn registry program and reviewed twice monthly. The ERAS protocol preoperative phase included standardization of outpatient screening, assessment, and electronic medical record documentation. The perioperative phase included standardization of preprocedural medications including multimodal analgesia. The intraoperative phase included standardization of medications and dressing application. Post procedural phase included standardized instructions for wound care and follow-up. Results Pre-implementation complications over a three-month period included one patient requiring wound care >1 week post laser treatment and 4 patients requiring narcotic administration >1 hour post procedure (16% of laser cases). Post-implementation of the ERAS program no complications were identified in 62 cases over a three-month period. Conclusions At our institution a burn scar specific ERAS protocol reduced perioperative complications following fractional CO2 laser procedures. While many opportunities exist to improve scarring and pain, the multidisciplinary approach in burn care is as essential for outpatients as it is for inpatients at reducing avoidable complications.
- Published
- 2021
42. 31 A phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered allogeneic cellularized construct in patients with deep partial-thickness thermal burns
- Author
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James H. Holmes, Steven Kahn, Leopoldo C. Cancio, Jeffrey W. Shupp, Joshua S Carson, Angela Gibson, Julie A Rizzo, Jeffrey E Carter, Tracee Short, Kevin N Foster, Jeffrey Litt, David J. Smith, Victor Joe, and B. Lynn Allen-Hoffmann
- Subjects
medicine.medical_specialty ,Standard of care ,business.industry ,Rehabilitation ,Trunk structure ,Diphtheria-Tetanus-Pertussis Vaccine ,Thermal burn ,Surgery ,law.invention ,Randomized controlled trial ,law ,Emergency Medicine ,medicine ,In patient ,Open label ,business ,Partial thickness - Abstract
Introduction Autograft (AG) is the standard of care for treatment of severe burns. While AG provides effective wound closure (WC), the procedure creates a donor site wound prone to pain and scarring. In a phase 1b trial, no deep partial-thickness (DPT) wound treated with a bioengineered allogeneic cellularized construct (BACC) required AG by Day 28 and WC at the BACC site was achieved in 93% of patients by Month (M) 3. This phase 3 study (NCT03005106) evaluated the efficacy and safety of this BACC in patients with DPT burns. Methods Enrolled patients were aged ≥18 years with 3–49% TBSA thermal burns on the torso or extremities. In each patient, two DPT areas (≤2,000 cm2 total) deemed comparable following excision were randomized to treatment with either cryopreserved BACC or AG. Coprimary endpoints were 1) the difference in percent area of BACC treatment site and AG treatment site autografted at M3 and 2) the proportion of patients achieving durable WC of the BACC treatment site without AG at M3. Ranked secondary endpoints were: 1) the difference between BACC and AG donor sites in average donor site pain intensity through Day 14; 2) the difference between BACC and AG donor site cosmesis at M3; and 3) the difference between BACC and AG treatment site cosmesis at M12. Safety assessments were performed in all patients through M12. Results Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of BACC treatment sites that required AG, compared with AG treatment sites (4.3% vs 102.1%, respectively; P Conclusions This phase 3 study achieved both coprimary endpoints, including significant autograft sparing and durable WC in DPT burns. Both donor site pain and donor site cosmesis were favorable outcomes of significantly reduced use of AG in BACC-treated patients. M12 POSAS for BACC did not differ significantly from AG. This BACC may offer a new treatment for severe burns to reduce or eliminate the need for AG. Applicability of Research to Practice This BACC has shown clinical benefit in patients with DPT thermal burns, potentially mitigating donor site morbidity. External Funding Stratatech, a Mallinckrodt Company; Funding and technical support for the Phase 3 clinical study were provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C.
- Published
- 2021
43. 664 'Minimally Invasive' Skin Grafting with Enzymatic Debridement and Autologous Skin Cell Spray
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James H. Holmes, Steven Kahn, Jordan Karsch, Ashley Hink, Elizabeth Halicki, Jeffrey E Carter, and William L. Hickerson
- Subjects
medicine.medical_specialty ,Debridement ,business.industry ,Dermabrasion ,medicine.medical_treatment ,Rehabilitation ,Pain management ,Surgery ,Transplantation ,medicine.anatomical_structure ,Skin cell ,Dermis ,Emergency Medicine ,medicine ,Skin grafting ,business ,Wound healing - Abstract
Introduction Minimally invasive surgery is increasingly becoming standard of care across numerous subspecialties. However, burn surgery has lagged behind; as the mainstay of reconstruction still involves wound excision with a knife, a commensurately sized skin graft, and a painful donor site. In recent years, several new technologies have the potential to be used synergistically to perform “minimally invasive” skin grafts. Enzymatic debridement with bromelain and autologous skin cell spray (ASCS) have independently been shown to reduce the need for split-thickness skin graft (STSG) and decrease the donor site size when grafting is performed. Bromelain is more likely to preserve healthy dermis and ASCS allows an 80:1 expansion. Due to constraints regarding the temporal course of these products only being available via studies before one was FDA approved, these two therapies have not been utilized together in the US until recently. A paucity of literature regarding their use in combination currently exists. Methods This study is a single site review of patients treated the continued access study protocol for bromelain-based enzymatic debridement and with ASCS per the FDA-approved instructions for use. Enzymatic debridement was performed over a 4-hour period with appropriate analgesia. Deep partial-thickness burns with residual dermis were treated with ASCS after enzymatic debridement and superficial dermabrasion. Wounds were dressed with a small pore non-adherent film and layered gauze. Full-thickness burn injuries were treated with conventional STSG. Results Two patients were treated over a 2 week period. One was a 51 yr old male with 17% TBSA superficial and deep partial thickness flame burns, of which 11% were deemed deep enough to warrant treatment with enzymatic debridement. 15% TBSA was treated with ASCS including the arms, back, and posterior neck with a 24 sq cm donor site. Wound closure was noted post-operative day 7 with complete re-epithelialization. The second patient was a 21-year-old male with several comorbidities impairing wound healing (diabetes [HgbA1c of 9.9], scurvy, and zinc deficiency. He had deep-partial and full-thickness burns to bilateral feet. The dorsum of the right foot was reconstructed with ASCS only and a 6 sq cm donor site, and the left foot was treated with a 3:1 meshed STSG and ASCS overspray with 100% take. Conclusions Enzymatic debridement and ASCS can be utilized to treat deep partial-thickness burns with a “minimally invasive” reconstruction. The donor sites in both patients were much smaller than had they been treated with a conventional meshed STSG. Further study is needed to determine which subsets of patients and burn wound characteristics are optimal for this combination of technologies. More data regarding outcomes such as length of stay, costs, and scar formation compared to standard of care is also warranted.
- Published
- 2021
44. 45 Application of Machine Learning Models to Thermal Burn Patient Outcome Predictions in the Aftermath of a Nuclear Event
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Curt A Harris, Randy D. Kearns, Mark H Ebell, Jeffrey E Carter, and Morgan A Taylor
- Subjects
business.industry ,Event (relativity) ,Rehabilitation ,medicine.disease ,Causality ,Outcome (probability) ,Thermal burn ,Fire - disasters ,Health personnel ,Emergency Medicine ,Medicine ,Surgery ,Medical emergency ,business - Abstract
Introduction A nuclear disaster would generate an unprecedented volume of thermal burn patients from the explosion and subsequent mass fires (Figure 1). Prediction models characterizing outcomes for these patients may better equip healthcare providers and other responders to manage large scale nuclear events. Logistic regression models have traditionally been employed to develop prediction scores for mortality of all burn patients. However, other healthcare disciplines have increasingly transitioned to machine learning (ML) models, which are automatically generated and continually improved, potentially increasing predictive accuracy. Preliminary research suggests ML models can predict burn patient mortality more accurately than commonly used prediction scores. The purpose of this study is to examine the efficacy of various ML methods in assessing thermal burn patient mortality and length of stay in burn centers. Methods This retrospective study identified patients with fire/flame burn etiologies in the National Burn Repository between the years 2009 – 2018. Patients were randomly partitioned into a 67%/33% split for training and validation. A random forest model (RF) and an artificial neural network (ANN) were then constructed for each outcome, mortality and length of stay. These models were then compared to logistic regression models and previously developed prediction tools with similar outcomes using a combination of classification and regression metrics. Results During the study period, 82,404 burn patients with a thermal etiology were identified in the analysis. The ANN models will likely tend to overfit the data, which can be resolved by ending the model training early or adding additional regularization parameters. Further exploration of the advantages and limitations of these models is forthcoming as metric analyses become available. Conclusions In this proof-of-concept study, we anticipate that at least one ML model will predict the targeted outcomes of thermal burn patient mortality and length of stay as judged by the fidelity with which it matches the logistic regression analysis. These advancements can then help disaster preparedness programs consider resource limitations during catastrophic incidents resulting in burn injuries.
- Published
- 2021
45. 509 Use of a burn sepsis screening protocol results in lower antibiotic usage rates
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Catherine Vu, Sarah Bilbe, Jeffrey E Carter, Charles W Jastram, and Herb A. Phelan
- Subjects
Protocol (science) ,Sepsis ,medicine.medical_specialty ,medicine.drug_class ,business.industry ,Rehabilitation ,Antibiotics ,Emergency Medicine ,medicine ,Surgery ,medicine.disease ,Intensive care medicine ,business - Abstract
Introduction Antibiotic stewardship is widely recognized as being a necessary component of modern hospital care but remains difficult to put into practice particularly on burn services where the risk of infection is known to be higher than the general hospital population. Our burn service instituted a protocol for sepsis screening triggers and antibiotic usage, becoming the only unit in our hospital to do so. In-house quality metrics have shown this protocol to be successful in reducing utilization. Methods With the opening of our burn unit in April 2018, a burn sepsis screening protocol was put in place (see accompanying image). Briefly, the first level of screening consists of threshold hemodynamic and physiologic parameters. If these are met the pathway leads to drawing of basic laboratory tests plus lactate and procalcitonin. Group A findings consist of either Serum Lactic Acid >2.2mmol/Lor Procalcitonin >0.69ng/ml, and Group B findings consist of: Platelets < 100,000/mmorGlucose >150 mg/dL or New Insulin Requirement. If one finding from each of groups A and B are present, antibiotics are started, and a source work up is initiated. De-identified aggregate data on antibiotic usage are routinely tracked as a quality metric by our hospital’s Infection Control Committee. The results from calendar year 2019 are presented here for all antibiotics, vancomycin usage, and beta-lactam usage. One-way Analysis of Variance with Tukey’s post-hoc testing was used to analyze the differences in intravenous antibiotic usage rates between the Burn Intensive Care Unit (BICU), the Trauma ICU (TICU), and the remainder of the hospital. Results The BICU used significantly fewer IV antibiotics than the TICU across all examined parameters and fewer than the remainder of the hospital for all antibiotics and vancomycin usage. Data is presented as antibiotic days/1000 patient days. Conclusions Initiation of a formal protocol for sepsis screening and IV antibiotic initiation significantly lowers antibiotic utilization. Future work will focus on this protocol’s impact on clinical outcomes.
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- 2021
46. 603 Evaluating real-world national and regional trends in definitive closure in US burn care: A survey of US Burn Centers
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Jeffrey E Carter, H Amani, Damien W Carter, Kevin N Foster, John A Griswold, William L Hickerson, James H Holmes, Samuel W Jones, General Surgery, Anjay Khandelwal, Nicole M Kopari, Jeffrey S Litt, Alisa Savetamal, Jeffrey W Shupp, Rajiv Sood, Cheryl P Ferrufino, Pratyusha Vadagam, Stacey Kowal, Tom Walsh, and Jeremiah Sparks
- Subjects
Rehabilitation ,Emergency Medicine ,Surgery - Abstract
Introduction Real-world data is observational data gathered outside of the experimental setting from diverse sources which is analyzed to produce real-world evidence. To better understand the impact of burn center treatment patterns, a national sample survey for real-world data sought to benchmark key burn center practice patterns, resource utilization, and clinical outcomes with national data contained within NBR version 8.0 (NBR). Methods A survey was developed by healthcare economists and burn specialists and administered to a representative sample of US burn centers. The survey collected information across several domains, including: burn center characteristics; patient characteristics including number of patients, and burn size and depth; aggregate number of types of procedures; and resource use such as autograft procedure time, length of stay (LOS), and dressing changes; and costs. Nuanced information was collected on care practices and patient outcomes for TBSA burns under 20%. Survey findings were aggregated by key outcomes (LOS, number of procedures, costs) nationally and regionally. Aggregated burn center data were also compared to the NBR to identify trends relative to current treatment patterns. Results Benchmarking survey results demonstrated shifts in burn center patient mix, with more severe cases being seen in the inpatient setting and less severe burns moving to the outpatient setting. Additionally, an overall reduction in the number of autograft procedures was observed compared to NBR, and time efficiencies improved as the intervention time per TBSA decreases with TBSA increases. Both nationally and regionally, an increase in costs were observed. Conclusions The results suggest resource use estimates from NBR version 8.0 may be higher than current practices, thus highlighting the importance of improved NBR reporting and further research on burn center standard of care practices. This study demonstrates significant variations in burn center characteristics, practice patterns, and resource utilization thus increasing our understanding of burn center operations and behavior.
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- 2021
47. 757 Mass Casualty Planning, When an Airplane Strikes a Building
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Randy D. Kearns and Jeffrey E Carter
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business.product_category ,Aeronautics ,business.industry ,Rehabilitation ,Emergency Medicine ,Medicine ,Surgery ,Mass Casualty ,business ,Airplane - Abstract
Introduction This paper focuses on the risks associated with the rapid development of aviation as well as the rapid growth of high-rise or large capacity buildings. The aim of the work is to further evaluate the incidence of building strikes involving aircraft. With this scenario, a burn injury is the most common for survivors. This paper will examine the nature and frequency of these events. Knowing the risks can aid the planning effort for all involved with a role in the response to a mass casualty incident. Methods The researchers reviewed historical records involving airplane crashes into large occupied buildings. This review included databases searched such as PubMed as well as commonly used search engines; Google and Bing. Inclusion criteria for buildings included those either considered mid-rise or high-rise (typically considered taller than 33 meters [108 feet]) or a large footprint (defined as 5000 square meters [54820 square feet]). Furthermore, the buildings had to be occupied. The airplanes included civilian (commercial) and military aircraft. The literature reviewed included historical accounts and historical references from a variety of news archival services that were chronicled in articles published and indexed in the PubMed search engine or found in common historical databases. The search also included the National Transportation Safety Board (NTSB) reports. Results Once the descriptive data were collected, the information was analyzed for similarities and trended where applicable. A total of 19 of the aircraft impacts were analyzed for this work. While death tolls were included in the results collected, the work aimed to identify the number of injured patients, and where possible, further identify those with burn injuries. All of the crashes also included the distance to the closest metro area (typically where a burn center was or should be located.) It should be noted that all of the buildings impacted were located within 50 kilometers (31 miles) of an airport with many of them occurring on or adjacent to airport property. Conclusions It is reasonable to presume that commercial or military aircraft that impact large occupied buildings such as a commercial complex, high-rise housing or an office building will produce disastrous consequences. This scenario includes significant casualties and loss of life. Findings from this research can offer insights from actual occurrences to disaster planners and emergency managers. Applicability of Research to Practice Mass casualty planning for burn centers should include the potential impact by aircraft and either large or high rise buildings. The size of the incident could be significant and the potential for the occurrence should not be overlooked.
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- 2020
48. T5 Preliminary Analysis of a Phase 3 Open-label, Controlled, Randomized Trial Evaluating the Efficacy and Safety of a Bioengineered Regenerative Skin Construct in Patients with Deep Partial-thickness Thermal Burns
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Leopoldo C. Cancio, Joshua S Carson, Jeffrey E Carter, Steven Kahn, Jeffrey Litt, Tracee Short, Kevin N Foster, Jeffrey W. Shupp, Victor Joe, James H. Holmes, Angela Gibson, David J. Smith, and Julie A Rizzo
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medicine.medical_specialty ,business.industry ,Rehabilitation ,Trunk structure ,Diphtheria-Tetanus-Pertussis Vaccine ,Thermal burn ,Surgery ,Preliminary analysis ,law.invention ,Randomized controlled trial ,law ,Emergency Medicine ,medicine ,In patient ,Open label ,business ,Partial thickness - Abstract
Introduction Autograft (AG) is the standard of care for treatment of severe burns. While AG provides effective wound closure (WC), the procedure creates a donor-site wound prone to dyspigmentation, infection, scarring, and pain. In a phase 1b trial, no deep partial-thickness (DPT) wound treated with a bioengineered regenerative skin construct (BRSC) required AG by Day 28 and WC at the BRSC site was achieved in 93% of patients by Month 3 (Holmes et al 2019). This phase 3 study evaluated the efficacy and safety of this BRSC in patients with DPT burns. Methods This phase 3 study (NCT03005106) enrolled patients aged ≥18 years with 3–49% total body surface area (TBSA) thermal burns on the torso or extremities. In each patient, two DPT areas (≤2,000 cm2 total) deemed comparable following excision were randomized to treatment with either cryopreserved BRSC or AG. Coprimary endpoints were 1) the difference in percent area of BRSC treatment site and AG treatment site autografted at 3 months and 2) the proportion of patients achieving durable WC of the BRSC treatment site without AG at 3 months. Safety assessments were performed in all patients. Efficacy was analyzed at 3 months and safety and scar follow-up continues to one year. Results A total of 71 patients were enrolled (mean [SD] age 44 [16] years; mean [SD] %TBSA 12.0 [8.4]). By Month 3, 4.3% (SD 21.6%) of all BRSC-treated area required AG compared with an additional regrafting of 2.1% of all AG-treated area (total 102.1% SD 13.1%; P< .0001). Three patients subsequently required AG at their BRSC site, 2 of whom also required it at their AG sites; Durable WC without autografting at the BRSC treatment site was achieved at Month 3 in 83% of patients compared with 86% of patients at the AG site. The most common BRSC-related adverse event (AE) was pruritus, occurring in 11 (15%) patients. All BRSC-related AEs were mild or moderate in severity. Conclusions This phase 3 study achieved both coprimary endpoints, including significant autograft sparing and durable WC in DPT burns. This BRSC may offer a new treatment for severe burns to reduce or eliminate the need for AG. Applicability of Research to Practice This BRSC has shown clinical benefit in patients with DPT thermal burns, potentially mitigating donor site morbidity. External Funding Stratatech, a Mallinckrodt Company; Funding and technical support for the Phase 3 clinical study were provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C.
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- 2020
49. 92 Improved Burn Healing Classification via Artificial Intelligence
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Ronald D Baxter, James H. Holmes, Jeffrey E Carter, Christopher K Craig, and Jeffrey W Williams
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Transplantation ,medicine.medical_specialty ,Burn therapy ,business.industry ,Rehabilitation ,Area under curve ,Emergency Medicine ,Medical imaging ,Medicine ,Surgery ,Radiology ,business ,Thermal burn - Abstract
Introduction Current methods of assessment for burn severity and healing potential are insufficient but this determination remains critical in providing optimal burn care. A novel device using multispectral imaging and artificial intelligence (AI) has shown prior success aiding in this process. Promising initial results of this proof-of-concept case series have been presented previously, invoking much interest from the burn care community. These results reflect the final results of this study and provide support for continued investigation with this device for the treatment of burn wounds. Methods Subjects with thermal burns were enrolled within 72 hours of injury. The goal was to enroll at least 12 burn wounds from each category of severity: 1°; superficial 2°; deep 2°; and 3°. Upon enrollment burns were imaged with the study device serially for up to 7 days post-burn. The true healing potential of each imaged burn area was determined using either healing assessment at 21 days post-burn or multiple punch biopsies of the burn wound taken at time of excision and grafting. This ground truth was used to train the AI algorithm to automatically identify the margins of non-healing burn tissue within device images. Accuracy of the study device to identify and differentiate healing and non-healing burn tissue within the captured wound area was computed. Results Data from 38 subjects with 58 total burns and 393 wound images were obtained during this study. Following completion of training, AI predictions achieved 90.7% sensitivity with 87.5% specificity in predicting non-healing burn tissue using cross-validation. Results improved throughout the study as more wound images were used in AI training (Figure 1). Conclusions The AI algorithm trained on 58 burn wounds (38 subjects) had an area under the curve of 0.955 and has continued to improve with the addition of more burn wounds. Expansion of this study has been initiated at multiple burn centers to continue collecting data for AI algorithm training. Applicability of Research to Practice These results demonstrate feasibility of utilizing AI-assisted diagnosis in burn wounds and possible application in the management of burn patients.
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- 2020
50. 56 Reduced Length of Stay with Autologous Skin Cell Suspension Reduces Burn Injuries
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Blake Platt, Charles T Tuggle, and Jeffrey E Carter
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medicine.medical_specialty ,Standard of care ,Burn therapy ,business.industry ,Rehabilitation ,Treatment outcome ,Skin transplantation ,Surgery ,Transplantation ,Skin cell ,Emergency Medicine ,Drug approval ,Medicine ,business ,Suspension (vehicle) - Abstract
Introduction Burn injuries remain a surgical challenge with few recent innovations. Grafting with split-thickness skin grafts (STSGs) has been the standard of care for decades. Although shown to have mortality benefits, STSGs are associated with significant morbidity in the form of pain and additional open wounds. For years, surgeons have looked for ways to decrease this associated morbidity. To that end, autologous skin cell suspension (ASCS) is a recently FDA-approved point of care regenerative medicine technology that reduces donor skin requirements without compromising clinical outcomes. Our study evaluated the cost and length of stay comparing STSG alone versus ASCS. Methods We obtained IRB-approval for single institution, retrospective chart review of patients age >14 years admitted with burn injuries from March 2018 – September 2018. Primary outcome was length of stay/%TBSA for patients undergoing STSG alone as compared to patients undergoing ASCS. The 2016 American Burn Association National Burn Repository (NBR) was used to benchmark LOS/%TBSA. Age, percentage burn injury (TBSA), LOS, mortality, and number of surgeries were reviewed. Student’s t-test was used to assess statistical significance of intragroup analysis. Results 36 patients were treated with ASCS in combination with meshed autografts for full-thickness acute burn injuries. 37 patients were treated with STSGs at our center. Mean age and %TBSA was 45.2 years and 6.6% for the STSG group and 46.0 years and 18.6% for the ASCS group. The LOS/%TBSA for the STSG was 1.72 versus 1.19 for the ASCS patients (p-value=0.02). The NBR predicts a LOS/%TBSA of 3.38 and 3.42 for the STSG and ASCS groups. Patients in the STSG group and ASCS group had statistically similar surgeries and mortalities. Conclusions Burn injured patients treated with ASCS had a decreased LOS/%TBSA when compared to both the STSGs and NBR predictions. ASCS is a novel technology allowing for point-of-care treatment that may decrease LOS for burn injured patients and should be considered as an adjunct to traditional techniques for burn patients. Applicability of Research to Practice Reduced length of stay compared to traditional burn care.
- Published
- 2020
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