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Randomized Controlled Trial Multicenter Study
A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT.
- Lior Rosenberg, Yuval Krieger, Alex Bogdanov-Berezovski, Eldad Silberstein, Yaron Shoham, and Adam J Singer.
- Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
- Burns. 2014 May 1;40(3):466-74.
ObjectivesExcisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, non-surgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.MethodsWe 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 4h) or SOC, which included surgical excisional or non-surgical debridement.ResultsNXB significantly reduced the time from injury to complete débridement (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.ConclusionsEnzymatic débridement 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.Trial RegistrationClinical Trials.gov NCT00324311.Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.
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