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, Adam J. Singer

    Research output: Contribution to journalArticlepeer-review

    156 Scopus citations

    Abstract

    Objectives Excisional 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. 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 non-surgical debridement. Results NXB 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. Conclusions Enzymatic 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 registration: Clinical Trials.gov NCT00324311.

    Original languageEnglish
    Pages (from-to)466-474
    Number of pages9
    JournalBurns
    Volume40
    Issue number3
    DOIs
    StatePublished - 1 Jan 2014

    Keywords

    • Bromelain
    • Burn wound
    • Debrase
    • Debridase
    • Debridement
    • Dermis preservation
    • Enzymatic debridement
    • Epithelialization
    • Eschar
    • Eschar removal
    • Escharectomy
    • Escharotomy
    • MVSS
    • NexoBrid
    • Quality of life
    • Scarring
    • Tangential excision

    ASJC Scopus subject areas

    • Surgery
    • Emergency Medicine
    • Critical Care and Intensive Care Medicine

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