Clinical Evaluation of a Viable Engineered Skin Tissue for Severe Burns: Post Hoc Analysis of a Phase 1b Randomized, Controlled, Clinical TrialJames H. Holmes IV, MD; Lee D. Faucher; and Steven E. Wolf
Introduction/Background: Excision and autografting is the standard of care for many burns. A viable engineered skin tissue (VEST; StrataGraft; Stratatech, a Mallinckrodt Company, Madison, WI) is being developed to reduce or eliminate the need for autograft in the treatment of thermal burns, thereby decreasing donor site morbidity.
Methods/Design: To evaluate the safety and efficacy of a VEST, a clinical trial (NCT01437852) was conducted in burn centers involving 30 patients with deep partial-thickness (DPT) burns. Comparable burns on each patient were randomized to receive either VEST or a control autograft following excision. Patients were enrolled in 3 cohorts: cohorts 1 and 2 (n = 10 each) received refrigerated VEST (≤ 220 cm2 and ≤ 440 cm2, respectively) and cohort 3 (n = 10) received cryopreserved VEST (≤ 440 cm2). Here the authors report a post hoc analysis that evaluated outcomes stratified by the size of the VEST treatment area (< 200 cm2 vs. ≥ 200 cm2).
Results/Findings: By day 28, no patient in any cohort underwent autografting at the VEST treatment site. By 3 months, the mean percent of the VEST treatment site that received autograft was 1.7% ± 6.5% and 7.1% ± 26.7% (< 200 cm2 and ≥ 200 cm2 groups, respectively). By 3 months, 100% (15/15) of the patients in the < 200 cm2 group and 86% (12/14) of the patients in the ≥ 200 cm2 group achieved wound closure. Mean percent reepithelialization of the VEST treatment site was not statistically different from the autograft control site in both treatment size groups by day 28 (P ≥ .25).
Conclusions/Implications: A novel VEST has the potential to promote wound healing in patients with DPT burns without the need for autografting. This post hoc analysis demonstrated the use of VEST results in substantial wound closure without autograft at 3 months. A phase 3 open-label, controlled, randomized study (NCT03005106) is ongoing.
*This poster won 1st place in the Clinical Research Category at the 2019 Symposium on Advanced Wound Care Fall.
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