Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial

SHOHAM, Yaron, Lior ROSENBERG, William HICKERSON, Jeremy GOVERMAN, Narayan IYER, Julio BARRERA-ORO, Břetislav LIPOVÝ, Stan MONSTREY, Sigrid BLOME-EBERWEIN, Lucy A WIBBENMEYER, Martin SCHARPENBERG a Adam J SINGER. Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial. JOURNAL OF BURN CARE & RESEARCH. OXFORD: OXFORD UNIV PRESS, 2024, 11 s. ISSN 1559-047X. Dostupné z: https://dx.doi.org/10.1093/jbcr/irad142.

Základní údaje

• Originální název: Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial
• Autoři: SHOHAM, Yaron, Lior ROSENBERG, William HICKERSON, Jeremy GOVERMAN, Narayan IYER, Julio BARRERA-ORO, Břetislav LIPOVÝ, Stan MONSTREY, Sigrid BLOME-EBERWEIN, Lucy A WIBBENMEYER, Martin SCHARPENBERG a Adam J SINGER.
• Vydání: JOURNAL OF BURN CARE & RESEARCH, OXFORD, OXFORD UNIV PRESS, 2024, 1559-047X.

Další údaje

• Originální jazyk: angličtina
• Typ výsledku: Článek v odborném periodiku
• Obor: 30212 Surgery
• Stát vydavatele: Velká Británie a Severní Irsko
• Utajení: není předmětem státního či obchodního tajemství
• WWW: URL
• Impakt faktor: Impact factor: 1.400 v roce 2022
• Organizační jednotka: Lékařská fakulta
• Doi: http://dx.doi.org/10.1093/jbcr/irad142
• UT WoS: 001077735400001
• Klíčová slova anglicky: burns; enzymatic debridement; eschar; surgery; excision; grafting
• Štítky: 14110229
• Příznaky: Mezinárodní význam, Recenzováno

Anotace

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.