Rapid Enzymatic Burn Debridement: A Review of the Paediatric Clinical Trial Experience

Overview

Journal Int Wound J

Specialties Emergency Medicine
Orthopedics

Date 2020 May 24

PMID 32445271

Citations 12

Authors

Yaron Shoham

Yuval Krieger

Guy Rubin

Ingo Koenigs

Bernd Hartmann

Frank Sander

Alexandra Schulz

Keren David

Lior Rosenberg

Eldad Silberstein

Affiliations

Soon will be listed here.

Abstract

NexoBrid (NXB) has been proven to be an effective selective enzymatic debridement agent in adults. This manuscript presents the combined clinical trial experience with NXB in children. Hundred and ten children aged 0.5 to 18 years suffering from deep thermal burns of up to 67% total body surface area were treated with NXB in three clinical trials. Seventy-seven children were treated with NXB in a phase I/II study, where 92.7% of the areas treated achieved complete eschar removal within 0.9 days from admission. Thirty-three children (17 NXB, 16 standard of care [SOC]) participated in a phase III randomized controlled trial. All wounds treated with NXB achieved complete eschar removal. Time to complete eschar removal (from informed consent) was 0.9 days for NXB vs 6.5 days for SOC (P < .001). The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001). Seventeen of these children participated in a phase III-b follow-up study (9 NXB and 8 SOC). The average long-term modified Vancouver Scar Scale scores were 3.4 for NXB-treated wounds vs 4.4 for SOC-treated wounds (NS). There were no significant treatment-related adverse events. Additional studies are needed to strengthen these results.

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