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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.

MedStar author(s):

Citation: Burns. 47(5):1024-1037, 2021 08.PMID: 34099322Institution: MedStar Health Research InstituteDepartment: Firefighters' Burn and Surgical Research LaboratoryForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Burns | *Skin Transplantation | Adult | Burns/su [Surgery] | Humans | Skin | Transplantation, Autologous | Treatment Outcome | Wound HealingYear: 2021 Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007ISSN:

0305-4179

Name of journal: Burns : journal of the International Society for Burn InjuriesAbstract: 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%).All authors: Allen-Hoffmann BL, Cancio L, Carson J, Carter JE, Comer AR, Foster K, Gibson ALF, Holmes JH 4th, Joe V, Kahn S, Litt J, Lokuta MA, Rizzo J, Short T, Shupp JW, Smiell JM, Smith DOriginally published: Burns. 2021 Apr 23Fiscal year: FY2022 Fiscal year of original publication: FY2021Digital Object Identifier:

https://dx.doi.org/10.1016/j.burns.2021.04.021

Date added to catalog: 2021-07-19

Holdings ( 1 )
Title notes ( 7 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	34099322	Available		34099322

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1996-2007

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%).

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