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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.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are conditions characterized by an immune-mediated skin reaction that results in blistering and epidermal detachment. Most cases are caused by drug hypersensitivity; however, recently there have been many publications documenting the association between coronavirus disease 2019 (COVID-19) and SJS/TEN. Our objective is to explore a case of a 4-year-old female who presented with a papular rash on her thighs that progressively worsened and spread to her face, trunk, and genital area. The patient tested positive for COVID-19. She required treatment with intravenous immunoglobulin (IVIG) and IV methylprednisolone, but eventually made a full recovery. This case underscores the need for awareness of the wide spectrum of dermatologic presentations in COVID-19 patients.

Introduction Residential fires account for the majority of burn-related injuries and fatalities. Established risk factors for burn injury include male gender, racial minority, children and elderly individuals, poverty, and substandard housing characteristics. In North Carolina, the rate of residential fire injuries and deaths is higher than the national average. Therefore, we sought to describe residential fire hospitalizations at a large regional burn center and describe the neighborhoods in which they live. We hypothesized that patients living in areas with higher Area Deprivation Index (ADI) are more likely to have major residential burns. Methods We conducted a retrospective analysis of burn admissions from January 2002 to December 2015. We dichotomized patients into two cohorts: residential and non-residential burns and performed a bivariate analysis. Multivariate Poisson regression models were utilized to determine if ADI was associated with inhalation injury and ≥20% total body surface area burn. Results Of the 10,506 patients presented during the study period. Of these, 10,016 (95.3%) patients resided in North Carolina, and 7894 (78.8%) had a residential burn. Of the overall cohort, 6.0% (n = 458) of patients had ≥20% TBSA burns and 6.4% (n = 506) had inhalation injury. The majority of patients were in the highest (most disadvantaged) ADI quartile (n = 3050, 39.5%), and only 6.8% of patients (n = 525) were in the lowest (least disadvantaged) ADI quartile. In the Poisson multivariate regressions to determine if the ADI was associated with severe burns, patients in the highest ADI quartile had an increased relative risk of ≥20% TBSA burn (RR 1.31, 95% CI 1.02–1.68) and inhalation injury (RR 1.39, 95% CI 1.09–1.76) when compared to patients in the second-lowest ADI quartile when controlled for pertinent covariates. Conclusion Residential structure fires represent the major source of burns and fatalities. People who reside in the highest ADI quartile are more like to present with higher burn injury severity in terms of burn size and the presence of inhalation injury. The use of the ADI to target neighborhoods for burn prevention is imperative.

Traumatic brain injury (TBI) is an underrecognized public health threat. Survivors of TBI often suffer long-term neurocognitive deficits leading to the progressive onset of neurodegenerative disease. Recent data suggests that the gut-brain axis is complicit in this process. However, no study has specifically addressed whether fecal microbiota transfer (FMT) attenuates neurologic deficits after TBI.We hypothesized that fecal microbiota transfer would attenuate neurocognitive, anatomic, and pathologic deficits after TBI.C57Bl/6 mice were subjected to severe TBI (n = 20) or sham-injury (n = 20) via an open-head controlled cortical impact. Post-injury, this cohort of mice underwent weekly oral gavage with a slurry of healthy mouse stool or vehicle alone beginning 1 h post-TBI followed by behavioral testing and neuropathologic analysis. 16S ribosomal RNA sequencing of fecal samples was performed to characterize gut microbial community structure pre- and post-injury. Zero maze and open field testing were used to evaluate post-traumatic anxiety, exploratory behavior, and generalized activity. 3D, contrast enhanced, magnetic resonance imaging was used to determine differences in cortical volume loss and white matter connectivity. Prior to euthanasia, brains were harvested for neuropathologic analysis.Fecal microbiome analysis revealed a large variance between TBI, and sham animals treated with vehicle, while FMT treated TBI mice had restoration of gut dysbiosis back to levels of control mice. Neurocognitive testing demonstrated a rescue of normal anxiety-like and exploratory behavior in TBI mice treated with FMT. FMT treated TBI mice spent a greater percentage of time (22%, P = 0.0001) in the center regions of the Open Field as compared to vehicle treated TBI mice (13%). Vehicle-treated TBI animals also spent less time (19%) in the open areas of zero maze than FMT treated TBI mice (30%, P = 0.0001). Comparing in TBI mice treated with FMT, MRI demonstrated a marked attenuation in ventriculomegaly (P 0.002) and a significant change in fractional anisotropy (i.e., loss of white matter connectivity) (P 0.0001). Histologic analysis of brain sections revealed a FMT- injury dependent interaction in the microglia/macrophage-specific ionized calcium-binding protein, Iba1 (P = 0.002).These data suggest that restoring a pre-injury gut microbial community structure may be a promising therapeutic intervention after TBI.

The addition of trauma to burn injuries may result in higher morbidity and mortality. The purpose of this study was to evaluate the outcomes of pediatric patients with a combination of burn and trauma injuries, and included all pediatric Burn only, Trauma only, and combined Burn-Trauma patients admitted between 2011 and 2020. Mean length of stay, ICU length of stay, and ventilator days were highest for the Burn-Trauma group. The odds of mortality were almost 13 times higher for the Burn-Trauma group when compared to the Burn only group ( P = .1299). After using inverse probability of treatment weighting, the odds of mortality were almost 10 times higher for the Burn-Trauma group in comparison to the Burn only group ( P < .0066). Thus, the addition of trauma to burn injuries was associated with increased odds of mortality, as well as longer ICU and overall hospital length of stay in this patient population.

Assessing the potential impact of telecommunications technology upon rural economic development, this study for the Economic Development Administration (EDA) employs data assembled and analyzed from the following: "informed experts;" research information and demonstration projects; and federal legislation, research, and agency interests. The intent was to provide information helpful for determining national policy about telecommunications research and development as related to rural areas; up to now, most attention has been on urban areas. The report covers demonstration projects in community, rural business, and economic development; education; health; information dissemination; and entertainment/recreational/cultural programming. The study shows: social and entertainment services have not been subjects of major demonstration programs, cost benefits are largely unexplored due to lack of measurement indicators incorporating quality of life factors, major projects should be regional in scale, importance of software programming is often neglected, effective telecommunications technologies can increase government efficiency, rural residents generally accept new technologies, a paucity of concrete findings exists, telecommunications programs can be comprehensive and pervasive. Recommendations involve legislation, regulation, public/private sector involvement, EDA's role. (RS)

Traumatic brain injury (TBI) has a bimodal age distribution with peak incidence at age 24 and age 65 with worse outcomes developing in aged populations. Few studies have specifically addressed age at the time of injury as an independent biologic variable in TBI-associated secondary pathology. Within the framework of our published work, identifying age related effects of TBI on neuropathology, cognition, memory and motor function we analyzed fecal pellets collected from young and aged TBI animals to assess for age-induced effects in TBI induced dysbiosis. In this follow up, work we hypothesized increased dysbiosis after TBI in aged (80-week-old, N=10) versus young (14-week-old, N=10) mice. C57BL/6 males received a sham incision or TBI via open-head controlled cortical impact. Fresh stool pellets were collected 1-day pre-TBI, then 1, 7, and 28-days post-TBI for 16S rRNA gene sequencing and taxonomic analysis. Data revealed an age induced increase in disease associated microbial species which were exacerbated by injury. Consistent with our hypothesis, aged mice demonstrated a high number of disease associated changes to the gut microbiome pre- and post-injury. Our data suggest divergent microbiome phenotypes in injury between young and aged reflecting a previously unknown interaction between age, TBI, and the gut-brain axis implying the need for different treatment strategies.

Designed as a 3-year pilot project, the Booker T. Washington High School Learning Laboratory emphasized the preparation of its disadvantaged Negro students for better job opportunities. Three consecutive experimental groups were to receive special training in language arts and mathematics, as well as special guidance. Three corresponding control groups were to be selected. The program ended after its second year because massive urban renewal and highway construction caused the phasing out of the high school. Rigorous evaluation of the program in terms of employment following high school and academic achievement was thus impossible. However, tentative experimental-control comparisons on post-high school employment, and on academic achievement using the Metropolitan Achievement Test, reveal that the experimental groups were always equal, and sometimes superior, to the control groups. A highly favorable result following the second year was that a large number of students in the initial experimental groups stayed in school in spite of urban renewal problems. See ED 019 704 for "Guidance Units" used in the project. [Urban renewal maps, pages B1 and B2, are not included with the document because of their marginal reproducibility.] (EM)

Objective This open-label, controlled, randomized study assessed the safety, tolerability, and efficacy of StrataGraft tissue compared to autograft in the treatment of deep partial-thickness (DPT) burns. Methods Thirty subjects with DPT thermal burns (3%–43% total body surface area) were treated with StrataGraft tissue as follows: cohort 1, ≤220 cm2 refrigerated tissue; cohort 2, ≤440 cm2 refrigerated tissue; and cohort 3, ≤440 cm2 cryopreserved tissue. On each subject, two comparable areas of DPT burn were randomized to receive StrataGraft tissue or autograft. Coprimary end points were the percent area of the StrataGraft tissue treatment site undergoing salvage autografting by Day 28 and wound closure of treatment sites by 3 months. Results By Day 28, no StrataGraft tissue treatment sites underwent autografting. By 3 months, 93% and 100% of the StrataGraft tissue and autograft treatment sites achieved complete wound closure, respectively. No significant differences in observer total and overall opinion POSAS scores between StrataGraft tissue and autograft treatment sites were observed at any timepoint. The most common adverse event was pruritus (17%). Conclusions StrataGraft tissue treatment of DPT thermal burns reduced the need for autograft, resulted in wound closure and treatment-site cosmesis comparable to that of autograft, and was well tolerated.

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.

Objectives Studies suggest that a restrictive transfusion strategy is safe in burns, yet the efficacy of a restrictive transfusion policy in massive burn injury is uncertain. Our objective: compare outcomes between massive burn (≥60% total body surface area (TBSA) burn) and major (20–59% TBSA) burn using a restrictive or a liberal blood transfusion strategy. Methods Patients with burns ≥20% were block randomized by age and TBSA to a restrictive (transfuse hemoglobin Results Three hundred and forty-five patients received 7,054 units blood, 2,886 in massive and 4,168 in restrictive. Patients were similar in age, TBSA, and inhalation injury. The restrictive group received less blood (45.57 ± 47.63 vs. 77.16 ± 55.0, p < 0.03 massive; 11.0 ± 16.70 vs. 16.78 ± 17.39, p < 0.001) major). In massive burn, the restrictive group had fewer ventilator days (p < 0.05). Median ICU days and LOS were lower in the restrictive group; wound healing, mortality, and infection did not differ. No significant outcome differences occurred in the major (20–59%) group (p > 0.05). Conclusions: A restrictive transfusion strategy may be beneficial in massive burns in reducing ventilator days, ICU days and blood utilization, but does not decrease infection, mortality, hospital LOS or wound healing.

Background and Objectives: Porcine xenografts have been used successfully in partial thickness burn treatment for many years. Their disappearance from the market led to the search for effective and efficient alternatives. In this article, we examine the synthetic epidermal skin substitute Suprathel® as a substitute in the treatment of partial thickness burns. Materials and Methods: A systematic review following the PRISMA guidelines has been performed. Sixteen Suprathel® and 12 porcine xenograft studies could be included. Advantages and disadvantages between the treatments and the studies’ primary endpoints have been investigated qualitatively and quantitatively. Results: Although Suprathel had a nearly six times larger TBSA in their studies (p < 0.001), it showed a significantly lower necessity for skin grafts (p < 0.001), and we found a significantly lower infection rate (p < 0.001) than in Porcine Xenografts. Nonetheless, no significant differences in the healing time (p = 0.67) and the number of dressing changes until complete wound healing (p = 0.139) could be found. Both products reduced pain to various degrees with the impression of a better performance of Suprathel® on a qualitative level. Porcine xenograft was not recommended for donor sites or coverage of sheet-transplanted keratinocytes, while Suprathel® was used successfully in both indications. Conclusion: The investigated parameters indicate that Suprathel® to be an effective replacement for porcine xenografts with even lower subsequent treatment rates. Suprathel® appears to be usable in an extended range of indications compared to porcine xenograft. Data heterogeneity limited conclusions from the results.