A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft R construct in patients with deep partial-thickness thermal burns.
A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft R construct in patients with deep partial-thickness thermal burns.
- 2021
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007
CLINICAL TRIAL IDENTIFIER: NCT03005106. Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. CONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting. METHODS: Patients aged >=18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (<=2000cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year. OBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns. RESULTS: Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).
English
0305-4179
10.1016/j.burns.2021.04.021 [doi] S0305-4179(21)00110-8 [pii]
*Burns
*Skin Transplantation
Adult
Burns/su [Surgery]
Humans
Skin
Transplantation, Autologous
Treatment Outcome
Wound Healing
MedStar Health Research Institute
Firefighters' Burn and Surgical Research Laboratory
Journal Article
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007
CLINICAL TRIAL IDENTIFIER: NCT03005106. Copyright (c) 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. CONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting. METHODS: Patients aged >=18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (<=2000cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year. OBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns. RESULTS: Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%).
English
0305-4179
10.1016/j.burns.2021.04.021 [doi] S0305-4179(21)00110-8 [pii]
*Burns
*Skin Transplantation
Adult
Burns/su [Surgery]
Humans
Skin
Transplantation, Autologous
Treatment Outcome
Wound Healing
MedStar Health Research Institute
Firefighters' Burn and Surgical Research Laboratory
Journal Article