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

J 2024

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

SHOHAM, Yaron, Lior ROSENBERG, William HICKERSON, Jeremy GOVERMAN, Narayan IYER et. al.

Základní údaje

Originální název

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

Autoři

Vydání

JOURNAL OF BURN CARE & RESEARCH, OXFORD, OXFORD UNIV PRESS, 2024, 1559-047X

Další údaje

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

Odkazy

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

Změněno: 19. 8. 2024 10:23, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

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.

@article{2371860,
   author = {Shoham, Yaron and Rosenberg, Lior and Hickerson, William and Goverman, Jeremy and Iyer, Narayan and BarreraandOro, Julio and Lipový, Břetislav and Monstrey, Stan and BlomeandEberwein, Sigrid and Wibbenmeyer, Lucy A and Scharpenberg, Martin and Singer, Adam J},
   article_location = {OXFORD},
   doi = {http://dx.doi.org/10.1093/jbcr/irad142},
   keywords = {burns; enzymatic debridement; eschar; surgery; excision; grafting},
   language = {eng},
   issn = {1559-047X},
   journal = {JOURNAL OF BURN CARE & RESEARCH},
   title = {Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial},
   url = {https://academic.oup.com/jbcr/advance-article/doi/10.1093/jbcr/irad142/7275687?login=true},
   year = {2024}
}

TY  - JOUR
ID  - 2371860
AU  - Shoham, Yaron - Rosenberg, Lior - Hickerson, William - Goverman, Jeremy - Iyer, Narayan - Barrera-Oro, Julio - Lipový, Břetislav - Monstrey, Stan - Blome-Eberwein, Sigrid - Wibbenmeyer, Lucy A - Scharpenberg, Martin - Singer, Adam J
PY  - 2024
TI  - Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial
JF  - JOURNAL OF BURN CARE & RESEARCH
PB  - OXFORD UNIV PRESS
SN  - 1559047X
KW  - burns
KW  - enzymatic debridement
KW  - eschar
KW  - surgery
KW  - excision
KW  - grafting
UR  - https://academic.oup.com/jbcr/advance-article/doi/10.1093/jbcr/irad142/7275687?login=true
N2  - 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.
ER  -

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. \textit{JOURNAL OF BURN CARE \&{}amp; RESEARCH}. OXFORD: OXFORD UNIV PRESS, 2024, 11 s. ISSN~1559-047X. Dostupné z: https://dx.doi.org/10.1093/jbcr/irad142.

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