IMPORTANCE Prehospital plasma administration improves survival in injured patients at risk for hemorrhagic shock and transported by air ambulance. Traumatic brain injury (TBI) is a leading cause of death following trauma, but few early interventions improve outcomes. OBJECTIVE To assess the association between prehospital plasma and survival in patients with TBI. DESIGN, SETTING, AND PARTICIPANTS The Prehospital Air Medical Plasma (PAMPer) trial was a pragmatic, multicenter, phase 3, cluster randomized clinical trial involving injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center. The trial was conducted at 6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases). The original trial analyzed 501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation. This secondary analysis of a predefined subgroup included patients with TBI. Data analysis was performed from October 2019 to February 2020. INTERVENTIONS Patients were randomized to receive standard care fluid resuscitation or 2 units of thawed plasma. MAIN OUTCOMES AND MEASURES The primary outcome was mortality at 30 days. Patients with TBI were prespecified as a subgroup for secondary analysis and for measurement of markers of brain injury. The 30-day survival benefit of prehospital plasma in subgroups with and without TBI as diagnosed by computed tomography was characterized using Kaplan-Meier survival analysis and Cox proportional hazard regression. RESULTS In total, 166 patients had TBI (median [interquartile range] age, 43.00 [25.00-59.75] years; 125 men [75.3%]). When compared with the 92 patients who received standard care, the 74 patients with TBI who received prehospital plasma had improved 30-day survival even after adjustment for multiple confounders and assessment of the degree of brain injury with clinical variables and biomarkers (hazard ratio [HR], 0.55; 95% CI, 0.33-0.94; P = .03). Receipt of prehospital plasma was associated with improved survival among patients with TBI with a prehospital Glasgow Coma Scale score of less than 8 (HR, 0.56; 95% CI, 0.35-0.91) and those with polytrauma (HR, 0.50; 95% CI, 0.28-0.89). Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).

Severe injuries to peripheral nerves are challenging to repair. Standard-of-care treatment for nerve gaps >2 to 3 centimeters is autografting; however, autografting can result in neuroma formation, loss of sensory function at the donor site, and increased operative time. To address the need for a synthetic nerve conduit to treat large nerve gaps, we investigated a biodegradable poly(caprolactone) (PCL) conduit with embedded double-walled polymeric microspheres encapsulating glial cell line–derived neurotrophic factor (GDNF) capable of providing a sustained release of GDNF for >50 days in a 5-centimeter nerve defect in a rhesus macaque model. The GDNF-eluting conduit (PCL/GDNF) was compared to a median nerve autograft and a PCL conduit containing empty microspheres (PCL/Empty). Functional testing demonstrated similar functional recovery between the PCL/GDNF-treated group (75.64 ± 10.28%) and the autograft-treated group (77.49 ± 19.28%); both groups were statistically improved compared to PCL/Empty-treated group (44.95 ± 26.94%). Nerve conduction velocity 1 year after surgery was increased in the PCL/GDNF-treated macaques (31.41 ± 15.34 meters/second) compared to autograft (25.45 ± 3.96 meters/second) and PCL/Empty (12.60 ± 3.89 meters/second) treatment. Histological analyses included assessment of Schwann cell presence, myelination of axons, nerve fiber density, and g-ratio. PCL/GDNF group exhibited a statistically greater average area occupied by individual Schwann cells at the distal nerve (11.60 ± 33.01 μm2) compared to autograft (4.62 ± 3.99 μm2) and PCL/Empty (4.52 ± 5.16 μm2) treatment groups. This study demonstrates the efficacious bridging of a long peripheral nerve gap in a nonhuman primate model using an acellular, biodegradable nerve conduit.

No abstract

Infection is the most significant complication in breast reconstruction surgery. While the Center for Disease Control and Prevention (CDC) is the most prevalent tool for surgical site infection (SSI) diagnosis, ASEPSIS and Southampton scoring methods have been speculated to be more sensitive. The ASEPSIS scoring system previously demonstrated much better interrater reliability than the CDC. We sought to assess the predictive value of various wound scoring methods in breast reconstruction SSIs. A retrospective analysis of all single-institution breast reconstruction infections from January 2013 to June 2016 was performed. Patients' postoperative wound-related complications were collected. Southampton, CDC, and modified ASEPSIS scores-extended to 30 postoperative days-were calculated. Relative predictive values for implantbased reconstruction were evaluated. Among the 22 reviewed cases, ASEPSIS scores greater than 30 resulted in a more than 50% rate of implant-based breast reconstruction failure. There was a significant positive correlation between ASEPSIS score and failure rate (P ¼ .022). A Southampton classification of B-minor complication (60% failure)-had a greater associative risk of reconstruction failure than a classification of C-major complication (23% failure)-or classification of D-major hematoma (0% failure). The CDC score had no predictive value of success versus failure of reconstruction. While the CDC criteria and Southampton scoring systems demonstrated little clinical use, the ASEPSIS scoring system shows substantial predictive value for breast reconstruction SSIs. New procedure protocols should be implemented to require detailed surgical notes including the proportion of the wounds affected by inflammatory responses to allow for easier wound score calculation by these alternate scoring systems. Résumé Une analyse comparative des méthodes d'infection des plaies chirurgicales : les valeurs prédictives des systèmes de score du CDC, de l'ASEPSIS et de Southampton pourévaluer les infections au siè ge de reconstruction mammaire : L'infection est la principale complication en cas de reconstruction mammaire. L'outil du Center for Disease Control (CDC) est le plus prévalent pour diagnostiquer l'infection au siège de l'opération, mais on spécule que les méthodes de score de l'ASEPSIS et de Southampton sont plus sensibles. L'ASEPSIS a déjà démontré une fiabilité interévaluateur bien meilleure que l'outil du CDC. Les chercheurs ont cherché àévaluer la valeur prédictive de diverses méthodes de score des plaies en cas d'infection au siège de la reconstruction mammaire. Les chercheurs ont effectué une analyse rétrospective de toutes les infections des reconstructions mammaires dans un seulétablissement entre janvier 2013 et juin 2016. Ils ont colligé les complications liées aux plaies postopératoires des patients. Ils ont calculé les scores de Southampton, de CDC et de l'ASEPSIS modifiés, prolongées jusqu'à 30 jours après l'opération, etévalué les valeurs prédictives relatives des reconstructions mammaires par ...

Background Professional burnout represents a significant threat to the American healthcare system. Organizational and individual factors may increase healthcare providers’ susceptibility or resistance to burnout. We hypothesized that during the COVID-19 pandemic, 1) higher levels of perceived organizational support (POS) are associated with lower risk for burnout and anxiety, and 2) anxiety mediates the association between POS and burnout. Methods In this longitudinal prospective study, we surveyed healthcare providers employed full-time at a large, multihospital healthcare system monthly over 6 months (April to November 2020). Participants were randomized using a 1:1 allocation stratified by provider type, gender, and academic hospital status to receive one of two versions of the survey instrument formulated with different ordering of the measures to minimize response bias due to context effects. The exposure of interest was POS measured using the validated 8-item Survey of POS (SPOS) scale. Primary outcomes of interest were anxiety and risk for burnout as measured by the validated 10-item Burnout scale from the Professional Quality (Pro-QOL) instrument and 4-item Emotional Distress-Anxiety short form of the Patient Reported Outcome Measurement Information System (PROMIS) scale, respectively. Linear mixed models evaluated the associations between POS and both burnout and anxiety. A mediation analysis evaluated whether anxiety mediated the POS-burnout association. Results Of the 538 participants recruited, 402 (75%) were included in the primary analysis. 55% of participants were physicians, 73% 25–44 years of age, 73% female, 83% White, and 44% had ≥1 dependent. Higher POS was significantly associated with a lower risk for burnout (-0.23; 95% CI -0.26, -0.21; p<0.001) and lower degree of anxiety (-0.07; 95% CI -0.09, -0.06; p = 0.010). Anxiety mediated the associated between POS and burnout (direct effect -0.17; 95% CI -0.21, -0.13; p<0.001; total effect -0.23; 95% CI -0.28, -0.19; p<0.001). Conclusion During a health crisis, increasing the organizational support perceived by healthcare employees may reduce the risk for burnout through a reduction in anxiety. Improving the relationship between healthcare organizations and the individuals they employ may reduce detrimental effects of psychological distress among healthcare providers and ultimately improve patient care.

No abstract

American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) created the Surgical Risk Calculator, to allow physicians to offer patients a risk-adjusted 30-day surgical outcome prediction. This tool has not yet been validated in plastic surgery. A retrospective analysis of all plastic surgery-specific complications from a quality assurance database from September 2013 through July 2015 was performed. Patient preoperative risk factors were entered into the ACS Surgical Risk Calculator, and predicted outcomes were compared with actual morbidities. The difference in average predicted complication rate versus the actual rate of complication within this population was examined. Within the study population of patients with complications (n=104), the calculator accurately predicted an above average risk for 20.90% of serious complications. For surgical site infections, the average predicted risk for the study population was 3.30%; this prediction was proven only 24.39% accurate. The actual incidence of any complication within the 4924 patients treated in our plastic surgery practice from September 2013 through June 2015 was 1.89%. The most common plastic surgery complications include seroma, hematoma, dehiscence and flap-related complications. The ACS Risk Calculator does not present rates for these risks. While most frequent outcomes fall into general risk calculator categories, the difference in predicted versus actual complication rates indicates that this tool does not accurately predict outcomes in plastic surgery. The ACS Surgical Risk Calculator is not a valid tool for the field of plastic surgery without further research to develop accurate risk stratification tools.

Objectives With increased focus on early resuscitation methods following injury to improve patient outcomes, studies are employing exception from informed consent (EFIC) enrollment. Few studies have assessed patients’ opinions following participation in an EFIC study, and none have been conducted within the realm of traumatic hemorrhage. We surveyed those patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research. Methods Telephone calls were made between January–June 2019 to all patients who were enrolled under EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled, May 2014-Oct 2017) and their surrogates. Questions gauging approval of EFIC enrollment were asked before discussion of PAMPer trial outcomes, after disclosure of positive outcomes, and after a hypothetical negative trial outcome was proposed. Results Of the total 647 telephone calls made, ninety-three interviews, reflecting 70 of 169 patient enrollments, were conducted. This included 13 in which only the patient was interviewed, 23 in which the patient and a surrogate were interviewed, and 34 in which only a surrogate was interviewed. Nearly half (48.4%) of respondents did not recall their personal or family member enrollment in the study. No patients or surrogates recalled hearing about the study through community consultation or being aware of opt out procedures. Patients and surrogates were glad they were enrolled (90.3%), agreed with EFIC use for their personal enrollment (88.17%), and agreed with the general use of EFIC for the PAMPer study (81.7%). Disclosure of the true positive PAMPer study outcome resulted in a significant increase in opinions regarding personal enrollment, EFIC for personal enrollment, and EFIC for general enrollment (all p < 0.001). Disclosure of a hypothetical neutral or negative study outcome resulted in significant decreases in opinions regarding EFIC for personal enrollment (p = 0.003) and EFIC for general enrollment (p < 0.001). Conclusions Clinical trial participants with traumatic hemorrhagic shock enrolled with EFIC, and surrogates of such participants, are generally accepting of EFIC. The results of the trial in which EFIC was utilized significantly affected patient and surrogate agreement with personal and general EFIC enrollment.