Journal article
Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial
Journal of burn care & research, Vol.45(2), pp.297-307
03/04/2024
DOI: 10.1093/jbcr/irad142
PMID: 37715999
Abstract
Since 1970 surgeons have managed deep burns by surgical debridement and autografting. We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as standard of care (SOC). In this Phase 3 trial, we randomly assigned adults with deep burns (covering 3-30% of total body surface area [TBSA]) to NexoBrid, surgical or nonsurgical SOC, or placebo Gel Vehicle (GV) in a 3:3:1 ratio. The primary endpoint was complete eschar removal (ER) at the end of the debridement phase. Secondary outcomes were need for surgery, time to complete ER, and blood loss. Safety endpoints included wound closure and 12 and 24-months cosmesis on the Modified Vancouver Scar Scale. Patients were randomized to NexoBrid (n = 75), SOC (n = 75), and GV (n = 25). Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs 72%; P < .001). Median time to ER was 1.2 and 3.9 days for the NexoBrid and SOC respectively (P < .001). ER blood loss was lower in the NexoBrid than the SOC group (14 +/- 512 mL vs 814 +/- 1020 mL, respectively; P < .0001). MVSS scores at 12 and 24 months were noninferior in the NexoBrid versus SOC groups (3.7 +/- 2.1 vs 5.0 +/- 3.1 for the 12 months and 3.04 +/- 2.2 vs 3.30 +/- 2.76 for the 24 months). NexoBrid resulted in early complete ER in >90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.
Details
- Title: Subtitle
- Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial
- Creators
- Yaron Shoham - Ben Gurion Univ Negev, Soroka Univ Med Ctr, Fac Hlth Sci, Dept Plast Surg, IL-8400711 Beer Sheva, IsraelLior Rosenberg - Ben Gurion Univ Negev, Soroka Univ Med Ctr, Fac Hlth Sci, Dept Plast Surg, IL-8400711 Beer Sheva, IsraelWilliam Hickerson - Univ Tennessee, Hlth Sci Ctr, Coll Med, Dept Plast Surg, Memphis, TN 38163 USAJeremy Goverman - Biomedical Advanced Research and Development AuthorityNarayan Iyer - HHS, Burn & Blast Med Countermeasures Program, Div Chem Biol Radiol Nucl Countermeasures CBRN, BARDA,Adm Preparedness & Response ASPR, Washington, DC 20201 USAJulio Barrera-Oro - HHS, Burn & Blast Med Countermeasures Program, Div Chem Biol Radiol Nucl Countermeasures CBRN, BARDA,Adm Preparedness & Response ASPR, Washington, DC 20201 USABretislav Lipovy - Masaryk Univ, Univ Hosp Brno, Fac Med, Dept Burns & Plast Surg, Brno 60300, Czech RepublicStan Monstrey - Univ Hosp Ghent, Dept Plast & Reconstruct Surg, B-9000 Ghent, BelgiumSigrid Blome-Eberwein - Lehigh Valley Hlth Network, Allentown, PA 18102 USALucy A. Wibbenmeyer - University of Iowa, SurgeryMartin Scharpenberg - Univ Bremen, Kompetenzzentrum Klin Studien Bremen, D-28359 Bremen, GermanyAdam J. Singer - Stony Brook UniversityDETECT Investigators
- Resource Type
- Journal article
- Publication Details
- Journal of burn care & research, Vol.45(2), pp.297-307
- DOI
- 10.1093/jbcr/irad142
- PMID
- 37715999
- NLM abbreviation
- J Burn Care Res
- ISSN
- 1559-047X
- eISSN
- 1559-0488
- Publisher
- Oxford Univ Press
- Number of pages
- 11
- Grant note
- HHSO100201500035C / Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS) US Biomedical Advanced Research and Development Authority (BARDA)
- Language
- English
- Electronic publication date
- 09/16/2023
- Date published
- 03/04/2024
- Academic Unit
- Surgery; Injury Prevention Research Center
- Record Identifier
- 9984511955902771
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