Early enzymatic burn debridement - results of the DETECT multicenter Randomized Controlled Trial.
Publication/Presentation Date
9-16-2023
Abstract
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%; P90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.
ISSN
1559-0488
Published In/Presented At
Shoham, Y., Rosenberg, L., Hickerson, W., Goverman, J., Iyer, N., Barrera-Oro, J., Lipovy, B., Monstrey, S., Blome-Eberwein, S., Wibbenmeyer, L. A., Scharpenberg, M., Singer, A. J., & DETECT Investigators (2023). Early enzymatic burn debridement - results of the DETECT multicenter Randomized Controlled Trial. Journal of burn care & research : official publication of the American Burn Association, irad142. Advance online publication. https://doi.org/10.1093/jbcr/irad142
Disciplines
Medicine and Health Sciences
PubMedID
37715999
Department(s)
Department of Surgery
Document Type
Article