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


BACKGROUND
Clinical Trials.gov NCT00324311.
Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
Lior
L
Rosenberg
Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
Yuval
Y
Krieger
Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
Alex
A
Bogdanov-Berezovski
Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
Eldad
E
Silberstein
Department of Plastic and Reconstructive Surgery, Ben Gurion University, Faculty of Health Sciences, Beer-Sheba, Israel.
Yaron
Y
Shoham
Department of Emergency Medicine, Stony Brook University, Stony Brook, NY, United States. Electronic address: Adam.singer@stonybrook.edu.
Adam J
AJ
Singer
D000293:Adolescent; D000328:Adult; D001963:Bromelains / Q000627:therapeutic use*; D002056:Burns / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003646:Debridement / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009779:Occlusive Dressings; D010447:Peptide Hydrolases / Q000627:therapeutic use*; D016038:Skin Transplantation / Q000379:methods*; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
D001963:Bromelains; D010447:Peptide Hydrolases
Bromelain; Burn wound; Debrase; Debridase; Debridement; Dermis preservation; Enzymatic debridement; Epithelialization; Eschar; Eschar removal; Escharectomy; Escharotomy; MVSS; NexoBrid; Quality of life; Scarring; Tangential excision