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Context: Despite the routine use of prophylactic systemic antibiotics, sternal wound infection still occurs in 5% or more of cardiac surgical patients and is associated with significant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries. A large, 2-center, randomized trial in Sweden reported in 2005 that the sponge reduced surgical site infection by 50% in cardiac patients.Objective: To test the hypothesis that the sponge prevents infection in cardiac surgical patients at increased risk for sternal wound infection.Design, Setting, and Participants: Phase 3 single-blind, prospective randomized controlled trial, 1502 cardiac surgical patients at high risk for sternal wound infection (diabetes, body mass index >30, or both) were enrolled at 48 US sites between December 21, 2007, and March 11, 2009.Intervention: Single-blind randomization to insertion of 2 gentamicin-collagen sponges (total gentamicin of 260 mg) between the sternal halves at surgical closure (n = 753) vs no intervention (control group: n = 749). All patients received standardized care including prophylactic systemic antibiotics and rigid sternal fixation.Main Outcome Measures: The primary end point was sternal wound infection occurring through 90 days postoperatively as adjudicated by a clinical events classification committee blinded to study treatment group. The primary study comparison was done in the intent-to-treat population. Secondary outcomes included (1) superficial wound infection (involving subcutaneous tissue but not extending down to sternal fixation wires), (2) deep wound infection (involving the sternal wires, sternal bone, and/or mediastinum), and (3) score for additional treatment, presence of serous discharge, erythema, purulent exudate, separation of the deep tissues, isolation of bacteria, and duration of inpatient stay (ASEPSIS; minimum score of 0 with no theoretical maximum).Results: Of 1502 patients, 1006 had diabetes (67%) and 1137 were obese (body mass index >30) (76%). In the primary analysis, there was no significant difference in sternal wound infection in 63 of 753 patients randomized to the gentamicin-collagen sponge group (8.4%) compared with 65 of 749 patients randomized to the control group (8.7%) (P = .83). No significant differences were observed between the gentamicin-collagen sponge group and the control group, respectively, in superficial sternal wound infection (49/753 [6.5%] vs 46/749 [6.1%]; P = .77), deep sternal wound infection (14/753 [1.9%] vs 19/749 [2.5%]; P = .37), ASEPSIS score (mean [SD], 1.9 [6.4] vs 2.0 [7.2]; P = .67), or rehospitalization for sternal wound infection (23/753 [3.1%] vs 24/749 [3.2%]; P = .87).Conclusion: Among US patients with diabetes, high body mass index, or both undergoing cardiac surgery, the use of 2 gentamicin-collagen sponges compared with no intervention did not reduce the 90-day sternal wound infection rate.Trial Registration: clinicaltrials.gov Identifier: NCT00600483. [ABSTRACT FROM AUTHOR]

Context: Coronary artery bypass graft (CABG) surgery is frequently performed and effective; however, perioperative complications related to ischemia-reperfusion injury, including myocardial infarction (MI), remain common and result in significant morbidity and mortality. MC-1, a naturally occurring pyridoxine metabolite and purinergic receptor antagonist, prevents cellular calcium overload and may reduce ischemia-reperfusion injury. Phase 2 trial data suggest that MC-1 may reduce death or MI in high-risk patients undergoing CABG surgery.Objective: To assess the efficacy and safety of MC-1 administered immediately before and for 30 days after surgery in patients undergoing CABG surgery.Design, Setting, and Participants: The MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery II Trial, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial, with 3023 intermediate- to high-risk patients undergoing CABG surgery with cardiopulmonary bypass enrolled between October 2006 and September 2007 at 130 sites in Canada, the United States, and Germany.Interventions: Patients received either MC-1, 250 mg/d (n = 1519), or matching placebo (n = 1504) immediately before and for 30 days after CABG surgery.Main Outcome Measures: The primary efficacy outcome was cardiovascular death or nonfatal MI, defined as a creatine kinase (CK) MB fraction of at least 100 ng/mL or new Q waves through postoperative day 30.Results: The primary efficacy outcome occurred in 140 of 1510 patients (9.3%) in the MC-1 group and 133 of 1486 patients (9.0%) in the placebo group (risk ratio, 1.04; 95% confidence interval, 0.83-1.30; P = .76). All-cause mortality was higher among patients assigned to MC-1 than placebo at 4 days (1.0% vs 0.3%; P = .03) but was similar at 30 days (1.9% vs 1.5%; P = .44). There was no difference in the 8- to 24-hour CK-MB area under the curve between the MC-1 and placebo groups (median, 270 [interquartile range, 175-492] vs 268 [interquartile range, 170-456] hours x ng/mL; P = .11).Conclusion: In this population of intermediate- to high-risk patients undergoing CABG surgery, MC-1 did not reduce the composite of cardiovascular death or nonfatal MI.Trial Registration: clinicaltrials.gov Identifier: NCT00402506 [ABSTRACT FROM AUTHOR]

Low levels of naturally occurring antibodies to the core section of endotoxin (EndoCAb) have been shown to be predictors of poor outcome following major surgery. We performed a retrospective study comparing pre-operative levels in US surgical patients, UK surgical patients and healthy volunteers. Both IgM and IgG EndoCAb levels were higher in the US surgical patients when compared with the other groups (approximately twice as high in the case of IgG EndoCAb). This may reflect genetic or environmental variability between the patient groups, differences in the disease processes, the disparity in the delivery of health care between the two countries or degradation of the samples in transfer. [ABSTRACT FROM PUBLISHER]

Low levels of naturally occurring antibodies to the core section of endotoxin (EndoCAb) have been shown to be predictors of poor outcome following major surgery. We performed a retrospective study comparing pre-operative levels in US surgical patients, UK surgical patients and healthy volunteers. Both IgM and IgG EndoCAb levels were higher in the US surgical patients when compared with the other groups (approximately twice as high in the case of IgG EndoCAb). This may reflect genetic or environmental variability between the patient groups, differences in the disease processes, the disparity in the delivery of health care between the two countries or degradation of the samples in transfer. [ABSTRACT FROM AUTHOR]

The article discusses the Red-Cell Storage Duration Study (RECESS), a randomized trial conducted by the Transfusion Medicine and Hemostasis Clinical Trials Network (TMHCTN) at various U.S. hospitals from January 2010 through January 2014 that focused on the clinical effect of the duration of red-cell storage on patients undergoing cardiac surgery. It found that there is no association between the duration of red-cell storage and the change in Multiple Organ Dysfunction Score (MODS).

Competing Interests: Disclosures The authors have no conflicts of interest to disclose.

Competing Interests: Competing interests: None declared.

Introduction Controlled substance waste processes in perioperative areas can be cumbersome. Streamlining this process is a critical component of improving operating room efficiency. At our institution, unused controlled substances require a two-person waste prior to disposal. We hypothesized that access to a centrally located automated medication dispensing system to conduct medication waste would decrease the amount of time required to perform a two-person waste and dispose of unused medications after the completion of a case. We further hypothesized that a decrease in the time required to waste would improve user satisfaction with the waste process. Methods This was a single-center, retrospective, IRB-approved quality assurance analysis. Research Electronic Data Capture (REDCap, Stony Brook, NY, United States) software was used to design an anonymous survey, which was distributed via email from 06/09/2021 to 09/09/2021. Wilcoxon signed-rank tests were used to compare before and after paired responses for individuals. Analyses were performed using SAS 9.4 © (Cary, NC, United States) software. Results Participants reported a significant decrease in time carrying used narcotics after a surgical case. For the primary outcome, median (IQR) scores demonstrated a significant decrease from 2, representing "10-20 minutes" (IQR 1-3), to 1, indicating "<10 minutes" (IQR 1-2) spent carrying used narcotics (p < 0.0001). Reported satisfaction with the process significantly increased from 2 to 3 points, on a scale of 5, after using the new centrally located Pyxis (p < 0.0001). Participants reported the wasting process as less time-consuming, carried fewer used controlled substances, and were less likely to wait until the end of the shift to waste. Conclusions By improving the ergonomics of the waste process after adding a Pyxis system in a more central location, the time anesthesia clinicians spent carrying used controlled substances decreased. Additionally, provider satisfaction increased, likely related to the ease of finding a partner to witness wasted medications., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Review Board issued approval IRB2022-00122. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Parikh et al.)