A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103).

BACKGROUND AND OBJECTIVE: Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI. METHODS: Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding. RESULTS: Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ±â€Š15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ±â€Š2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP. CONCLUSION: Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.

Major hemorrhage from hepatic laceration after cardiopulmonary resuscitation.

Visceral injury from cardiac arrest resuscitation is a rare but potentially life-threatening complication. We describe and review 2 cases of hepatic laceration complicated by major abdominal hemorrhage manifested as delayed shock following cardiopulmonary resuscitation after cardiac arrest. Two patients enrolled in our institutional post cardiac arrest resuscitation clinical pathway had evidence of major liver laceration presenting as delayed shock due to massive hemoperitoneum. Case analysis revealed coagulopathy due to systemic anticoagulation as a risk factor for major hemorrhage. Both cases were successfully managed via hepatic artery embolization. Visceral abdominal injuries are an uncommon but important complication of cardiopulmonary resuscitation.Coagulopathy, including therapeutic systemic anticoagulation, is a risk factor for clinically significant hemorrhage.

A little slower, but just as good: postgraduate year resident versus attending outcomes in laparoscopic ventral hernia repair.

INTRODUCTION: The purpose of this study was to analyze the effect of residents on patient outcomes in laparoscopic ventral hernia repair (LVHR).We hypothesized that increasing postgraduate year (PGY) level would correlate with better outcomes. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried from 2005 to 2011 for elective LVHR. Attending only cases were used as the control, and resident cases were stratified into junior (PGY 1-3), chief (4-5), and fellow (6+) cases. Standard statistical tests and multivariate regression controlling for age, body mass index, Charlson comorbidity index, smoking, functional status, and inpatient cases were performed for trainee involvement and PGY level. RESULTS: There were 6,841 ventral hernia repairs that met inclusion criteria: 2,773 attending and 4,068 resident cases. There were 1,644 junior, 1,983 chief, and 441 fellow cases. Patients were similar between the attending and resident groups. The resident group had a higher rate of inpatient cases, general complications, longer operative time, and hospital length of stay. After controlling for confounders in multivariate analysis, only operative time was significantly different; resident cases were 17.7 min longer (CI 15.0-20.6; p < 0.001). There was no significant difference in the rate of wound or major complications, readmission, reoperation, or mortality between attending and resident cases. Demographics were not significantly different between the PGY level strata. On multivariate regression by PGY level with attending alone as the reference, only operative time was significantly different. Juniors (15.7 min, CI 12.2-19.2), chiefs (18.0 min, CI 14.7-21.3), and fellows (24.9 min, CI 19.1-30.7) had significantly longer cases than attending alone; all p < 0.001. CONCLUSION: Trainee involvement during LVHR does not change the clinical outcomes for patients as compared to those performed by an attending only. Operative time is significantly longer with increasing PGY level, perhaps indicating the complexity of the operation or increasing trainee involvement as primary surgeon. However, patient care does not suffer, affirming the current surgical training curriculum is appropriate.

Split fertilizer nitrogen application with a cereal rye cover crop reduces tile nitrate loads in a corn-soybean rotation.

Splitting fertilizer nitrogen (N) applications and using cover crops are management strategies to reduce nitrate in tile drainage water. We investigated split fertilizer N applications to corn (Zea mays L.) on crop yields and tile nitrate loss in both corn and soybean (Glycine max L.) in rotation from 2016 through 2019. We evaluated the inclusion of cover crops in a split-N treatment. Fertilizer N treatments included 100% in the fall; 50% in the fall + 25% at planting + 25% at side-dress; 100% as spring preplant; 75% as spring preplant (reduced N rate); 50% as spring preplant + 50% at side-dress; and 50% as spring preplant + 50% at side-dress with a cover crop. We did not find significant differences between split and single full rate N application treatments for corn yields or tile nitrate loss; however, the reduced N rate treatment significantly decreased corn yield by 10%. Cumulative tile nitrate losses (over four seasons) ranged from 115 kg ha-1 for all of the N in the fall to 65 kg ha-1 for 50% as spring preplant + 50% at side-dress with a cover crop, a decrease of 43%. Tile nitrate loss responded similarly to (corn) N treatments under both corn and soybean, with 64% of the loss under corn and 36% under soybean. Our results suggest that decreasing the fertilizer N rate may impact corn yield more than nitrate loss, while split fertilizer N application with a cover crop has potential to reduce tile nitrate loss without decreasing crop yield.

An initiative to assess and improve the resources and patient care processes used among Chest Wall Injury Society collaborative centers study (CWIS-CC2).

BACKGROUND: Over the last two decades, the acute management of rib fractures has changed significantly. In 2021, the Chest Wall injury Society (CWIS) began recognizing centers that epitomize their mission as CWIS Collaborative Centers. The primary aim of this study was to determine the resources, surgical expertise, access to care, and institutional support that are present among centers. METHODS: A survey was performed including all CWIS Collaborative Centers evaluating the resources available at their hospital for the treatment of patients with chest wall injury. Data about each chest wall injury center care process, availability of resources, institutional support, research support, and educational offerings were recorded. RESULTS: Data were collected from 20 trauma centers resulting in an 80% response rate. These trauma centers were made up of 5 international and 15 US-based trauma centers. Eighty percent (16 of 20) have dedicated care team members for the evaluation and management of rib fractures. Twenty-five percent (5 of 20) have a dedicated rib fracture service with a separate call schedule. Staffing for chest wall injury clinics consists of a multidisciplinary team: with attending surgeons in all clinics, 80% (8 of 10) with advanced practice providers and 70% (7 of 10) with care coordinators. Forty percent (8 of 20) of centers have dedicated rib fracture research support, and 35% (7 of 20) have surgical stabilization of rib fracture (SSRF)-related grants. Forty percent (8 of 20) of centers have marketing support, and 30% (8 of 20) have a web page support to bring awareness to their center. At these trauma centers, a median of 4 (1-9) surgeons perform SSRFs. In the majority of trauma centers, the trauma surgeons perform SSRF. CONCLUSION: Considerable similarities and differences exist within these CWIS collaborative centers. These differences in resources are hypothesis generating in determining the optimal chest wall injury center. These findings may generate several patient care and team process questions to optimize patient care, patient experience, provider satisfaction, research productivity, education, and outreach. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level V.

Atrial Cannulation During Resuscitative Clamshell Thoracotomy.

BACKGROUND: Resuscitative thoracotomy and clamshell thoracotomy are performed in the setting of traumatic arrest with the intent of controlling hemorrhage, relieving tamponade, and providing open chest cardiopulmonary resuscitation. Historically, return of spontaneous circulation rates for penetrating traumatic arrest as well as out of hospital survival have been reported as low as 40% and 10%. Vascular access can be challenging in patients who have undergone a traumatic arrest and can be a limiting step to effective resuscitation. Atrial cannulation is a well-established surgical technique in cardiac surgery. Herein, we present a case series detailing our application of this technique in the context of acute trauma resuscitation during clamshell thoracotomy for traumatic arrest in the emergency department. METHODS: A retrospective case series of atrial cannulation during traumatic arrest was conducted in Charlotte, NC at Carolinas Medical Center an urban level 1 trauma center. RESULTS: The mean rate of return of spontaneous circulation in our series, 60%, was greater than previously published upper limit of return of spontaneous circulation for penetrating causes of traumatic arrest. DISCUSSION: Intravenous access can be difficult to establish in the hypovolemic and exsanguinating patient. Traditional methods of vascular access may be insufficient in the setting of central vascular injury. Atrial appendage cannulation during atrial cannulation is a quick and reliable technique to achieve vascular access that employs common methods from cardiac surgery to improve resuscitation of traumatic arrest.

Attention to detail: A dedicated rib fracture consultation service leads to earlier operation and improved clinical outcomes.

BACKGROUND: Surgical stabilization of rib fractures (SSRF) has been correlated with improved outcomes, including decreased length of stay (LOS). We hypothesized that an SSRF consultation service would increase the frequency of SSRF and improve outcomes. METHODS: A prospective observational study was performed to compare outcomes before and after implementing an SSRF service. Primary outcome was time from admission to surgery; secondary outcomes included LOS, mortality and morphine milligram equivalents (MME) prescribed at discharge. RESULTS: 1865 patients met consultation criteria and 128 patients underwent SSRF. Mortality decreased (6.3% vs. 3%) and patients were prescribed fewer MME at discharge (328 MME vs. 124 MME) following implementation. For the operative cohort, time from admission to surgery decreased by 1.72 days and ICU LOS decreased by 2.6 days. CONCLUSION: Establishment of an SSRF service provides a mechanism to maximize capture and evaluation of operative candidates, provide earlier intervention, and improve patient outcomes. Additional study to determine which elements and techniques are most beneficial is warranted. LEVEL OF EVIDENCE: III.

Emergencies do not shut down during a pandemic: COVID pandemic impact on Acute Care Surgery volume and mortality at a level I trauma center.

BACKGROUND: The aim of this study was to evaluate the impact of the COVID-19 pandemic on volume and outcomes of Acute Care Surgery patients, and we hypothesized that inpatient mortality would increase due to COVID+ and resource constraints. METHODS: An American College of Surgeons verified Level I Trauma Center's trauma and operative emergency general surgery (EGS) registries were queried for all patients from Jan. 2019 to Dec. 2020. April 1st, 2020, was the demarcation date for pre- and during COVID pandemic. Primary outcome was inpatient mortality. RESULTS: There were 14,460 trauma and 3091 EGS patients, and month-over-month volumes of both remained similar (p > 0.05). Blunt trauma decreased by 7.4% and penetrating increased by 31%, with a concomitant 25% increase in initial operative management (p < 0.001). Despite this, trauma (3.7%) and EGS (2.9-3.0%) mortality rates remained stable which was confirmed on multivariate analysis; p > 0.05. COVID + mortality was 8.8% and 3.7% in trauma and EGS patients, respectively. CONCLUSION: Acute Care Surgeons provided high quality care to trauma and EGS patients during the pandemic without allowing excess mortality despite many hardships and resource constraints.

Operative experience in the era of duty hour restrictions: is broad-based general surgery training coming to an end?

Since the institution of Accreditation Council for Graduate Medical Education (ACGME) resident work hour restrictions, conflicting evidence exists regarding the impact on resident case volume with most data from single-institution studies. We examined the effect of restrictions on national resident operative experience. After permission from the ACGME, we reviewed the publicly available national resident case log data (1999 through 2008) maintained on the ACGME web site (www.acgme.org), including total major cases with subanalysis of the ACGME-specified categories. The mean cases per resident were compared before (1999 to 2003) and after (2003 to 2008) restrictions. After the implementation of duty hour restrictions, the mean number of total cases per resident significantly decreased (949 +/- 18 vs 911 +/- 14, P = 0.004). Subanalysis showed a significant increase in alimentary tract (217 +/- 7 vs 229 +/- 3, P = 0.004), skin/soft tissue (31 +/- 3 vs 36 +/- 1, P = 0.01), and endocrine (26 +/- 2 vs 31 +/- 2, P = 0.006) cases. However, we observed a significant decrease in head and neck (21 +/- 0.3 vs 20 +/- 0.3, P = 0.01), vascular (164 +/- 29 vs 126 +/- 5, P = 0.01), pediatric (41 +/- 1 vs 37 +/- 2, P = 0.006), genitourinary (10 +/- 2 vs 7 +/- 1, P = 0.004), gynecologic surgery (5 +/- 1 vs 3 +/- 0.6, P = 0.002), plastics (16 +/- 0.3 vs 15 +/- 0.7, P = 0.03), and endoscopy (91 +/- 3 vs 82 +/- 2, P < 0.001) procedures. Analysis of the ACGME-compiled national data confirms that duty hour restrictions have significantly impacted resident operative experience. Importantly, experience in specialty areas, including vascular and endoscopy, appears to have been sacrificed for consolidation of resources into general surgery services as indicated by the increase in alimentary tract and endocrine cases. These findings raise the following question: Is the era of truly broad-based general surgery training coming to an end?

A randomized prospective trial of airway pressure release ventilation and low tidal volume ventilation in adult trauma patients with acute respiratory failure.

BACKGROUND: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation, which has demonstrated potential benefits in trauma patients. We therefore sought to compare relevant pulmonary data and safety outcomes of this modality to the recommendations of the Adult Respiratory Distress Syndrome Network. METHODS: Patients admitted after traumatic injury requiring mechanical ventilation were randomized under a 72-hour waiver of consent to a respiratory protocol for APRV or low tidal volume ventilation (LOVT). Data were collected regarding demographics, Injury Severity Score, oxygenation, ventilation, airway pressure, failure of modality, tracheostomy, ventilator-associated pneumonia, ventilator days, length of stay (LOS), pneumothorax, and mortality. RESULTS: Sixty-three patients were enrolled during a 21-month period ending in February 2006. Thirty-one patients were assigned to APRV and 32 to LOVT. Patients were well matched for demographic variables with no differences between groups. Mean Acute Physiology and Chronic Health Evaluation II score was higher for APRV than LOVT (20.5 ± 5.35 vs. 16.9 ± 7.17) with a p value = 0.027. Outcome variables showed no differences between APRV and LOVT for ventilator days (10.49 days ± 7.23 days vs. 8.00 days ± 4.01 days), ICU LOS (16.47 days ± 12.83 days vs. 14.18 days ± 13.26 days), pneumothorax (0% vs. 3.1%), ventilator-associated pneumonia per patient (1.00 ± 0.86 vs. 0.56 ± 0.67), percent receiving tracheostomy (61.3% vs. 65.6%), percent failure of modality (12.9% vs. 15.6%), or percent mortality (6.45% vs. 6.25%). CONCLUSIONS: For patients sustaining significant trauma requiring mechanical ventilation for greater than 72 hours, APRV seems to have a similar safety profile as the LOVT. Trends for APRV patients to have increased ventilator days, ICU LOS, and ventilator-associated pneumonia may be explained by initial worse physiologic derangement demonstrated by higher Acute Physiology and Chronic Health Evaluation II scores.

Analysis of sex and race and the size and shape of the distal femur using virtual surgery and archived computed tomography images.

Anthropometric data and stature profiling are needed for the accurate sizing of prosthetic systems in total knee arthroplasty (TKA). The purpose of this study was to collect and analyze anthropometric knee data using a virtual surgical method. Computed tomography images (107) from patients (66) of three races were converted to virtual models and oriented with an anatomical coordinate system. The models were used to obtain anterior-posterior, medial-lateral, and condylar spacing measurements. Mean values for all measurements were larger for males than females in the overall population and within each race, and differences between races were observed. Comparisons of males to females from different races showed overlapping mean measurements for males of one race and females of another. These overlaps indicate that certain measurements relevant to TKA system sizing are not strictly related to sex.