Early enzymatic burn debridement - results of the DETECT multicenter Randomized Controlled Trial.

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) to NexoBrid, surgical or non-surgical 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 & 24-months cosmesis on the Modified Vancouver Scar Scale (MVSS). Patients were randomized to NexoBrid (n=75), SOC (n=75), and GV (n=25). Complete ER was higher in the NexoBrid vs. the GV group (93% vs. 4%; P<0.001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs. 72%; P<0.001). Median time to ER was 1.2 and 3.9 days for the NexoBrid and SOC respectively (P<0.001). ER blood loss was lower in the NexoBrid than the SOC group (14±512ml vs. 814±1020ml, respectively; P<0.0001). MVSS scores at 12 & 24 months were non-inferior in the NexoBrid vs. 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.