A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT

Objectives: Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, nonsurgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid (TM) (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC. Methods: We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4 h) or SOC, which included surgical excisional or nonsurgical debridement. Results: NXB significantly reduced the time from injury to complete debridement (2.2 vs. 8.7 days, P < 0.0001), need for surgery (24.5% vs. 70.0%, P < 0.0001), the area of burns excised (13.1% vs. 56.7%, P < 0.0001) and the need for autografting (17.9% vs. 34.1%, P = 0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events. Conclusions: Enzymatic debridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns. (C) 2013 Elsevier Ltd and ISBI. All rights reserved.