Yaron Shoham

Since 1970 surgeons have managed deep burns by surgical debridement and autografting. We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as standard of care (SOC). In this Phase 3 trial, we randomly assigned adults with deep burns (covering 3–30% of total body surface area [TBSA]) to NexoBrid, surgical or nonsurgical SOC, or placebo Gel Vehicle (GV) in a 3:3:1 ratio. The primary endpoint was complete eschar removal (ER) at the end of the debridement phase. Secondary outcomes were need for surgery, time to complete ER, and blood loss. Safety endpoints included wound closure and 12 and 24-months cosmesis on the Modified Vancouver Scar Scale. Patients were randomized to NexoBrid (n = 75), SOC (n = 75), and GV (n = 25). Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs 72%; P < .001). Median time to ER was 1.0 and 3.8 days for the NexoBrid and SOC respectively (P < .001). ER blood loss was lower in the NexoBrid than the SOC group (14 ± 512 mL vs 814 ± 1020 mL, respectively; P < .0001). MVSS scores at 12 and 24 months were noninferior in the NexoBrid versus SOC groups (3.7 ± 2.1 vs 5.0 ± 3.1 for the 12 months and 3.04 ± 2.2 vs 3.30 ± 2.76 for the 24 months). NexoBrid resulted in early complete ER in >90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.

Background: Blood stream infections are a significant cause of morbidity and mortality in burns, and pathogen identification is important for treatment. This study aims to characterize the microbiology of these infections and the association between the infecting pathogen and the hospitalization course. Methods: We conducted a cohort study that included records of burn patients treated at the Soroka University Medical Center between 2007–2020. Statistical analysis of demographic and clinical data was performed to explore relationships between burn characteristics and outcomes. Patients with positive blood cultures were divided into four groups: Gram-positive, Gram-negative, mixed-bacterial, and fungal. Results: Of the 2029 burn patients hospitalized, 11.7% had positive blood cultures. The most common pathogens were Candida and Pseudomonas. We found significant differences in ICU admission, need for surgery, and mortality between the infected and non-infected groups (p < 0.001). Pathogen groups differed significantly mean TBSA, ICU admission, need for surgery, and mortality (p < 0.001). Multivariate analysis showed flame (OR 2.84) and electric burns (OR 4.58) were independent risk factors for ICU admission and surgical intervention (p < 0.001). Gram-negative bacterial infection was found to be an independent predictor of mortality (OR = 9.29, p < 0.001). Conclusions: Anticipating specific pathogens which are associated with certain burn characteristics may help guide future therapy.