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A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT.
Burns 2014; 40(3):466-74B

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 4h) 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.

Authors+Show Affiliations

Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.Department of Emergency Medicine, Stony Brook University, Stony Brook, NY, United States. Electronic address: Adam.singer@stonybrook.edu.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24074719

Citation

Rosenberg, Lior, et al. "A Novel Rapid and Selective Enzymatic Debridement Agent for Burn Wound Management: a Multi-center RCT." Burns : Journal of the International Society for Burn Injuries, vol. 40, no. 3, 2014, pp. 466-74.
Rosenberg L, Krieger Y, Bogdanov-Berezovski A, et al. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014;40(3):466-74.
Rosenberg, L., Krieger, Y., Bogdanov-Berezovski, A., Silberstein, E., Shoham, Y., & Singer, A. J. (2014). A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns : Journal of the International Society for Burn Injuries, 40(3), pp. 466-74. doi:10.1016/j.burns.2013.08.013.
Rosenberg L, et al. A Novel Rapid and Selective Enzymatic Debridement Agent for Burn Wound Management: a Multi-center RCT. Burns. 2014;40(3):466-74. PubMed PMID: 24074719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. AU - Rosenberg,Lior, AU - Krieger,Yuval, AU - Bogdanov-Berezovski,Alex, AU - Silberstein,Eldad, AU - Shoham,Yaron, AU - Singer,Adam J, Y1 - 2013/09/26/ PY - 2013/01/18/received PY - 2013/08/07/revised PY - 2013/08/09/accepted PY - 2013/10/1/entrez PY - 2013/10/1/pubmed PY - 2014/11/11/medline KW - Bromelain KW - Burn wound KW - Debrase KW - Debridase KW - Debridement KW - Dermis preservation KW - Enzymatic debridement KW - Epithelialization KW - Eschar KW - Eschar removal KW - Escharectomy KW - Escharotomy KW - MVSS KW - NexoBrid KW - Quality of life KW - Scarring KW - Tangential excision SP - 466 EP - 74 JF - Burns : journal of the International Society for Burn Injuries JO - Burns VL - 40 IS - 3 N2 - 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 4h) 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. SN - 1879-1409 UR - https://www.unboundmedicine.com/medline/citation/24074719/A_novel_rapid_and_selective_enzymatic_debridement_agent_for_burn_wound_management:_a_multi_center_RCT_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0305-4179(13)00251-9 DB - PRIME DP - Unbound Medicine ER -