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A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.

Authors :
Holmes IV, James H.
Gibson, Angela L.F.
Short, Tracee
Joe, Victor C.
Litt, Jeffrey
Carson, Joshua
Carter, Jeffrey E.
Wibbenmeyer, Lucy
Hahn, Helen
Smiell, Janice M.
Rutan, Randi
Wu, Richard
Shupp, Jeffrey W.
Source :
Burns (03054179). Nov2024, Vol. 50 Issue 8, p2013-2022. 10p.
Publication Year :
2024

Abstract

A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements. Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs). Secondary endpoints included confirmed wound closure (WC) at Week 12, durable WC at Week 24, time to WC, scar evaluation, and wound infection-related events. Fifty-two patients with 96 treatment sites were enrolled. Pruritus was the most common TEAE (22 patients [42.3 %]). Twenty serious TEAEs occurred in 10 patients (19.2 %); none were related to StrataGraft. There were 4 (7.7 %) deaths (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis); none were related to StrataGraft. Confirmed WC was achieved by Week 12 in 33 patients (63.5 %; 95 % CI: 50.4–76.5 %) and 69 treatment sites (71.9 %; 95 % CI: 62.9–80.9 %). Durable WC was achieved by Week 24 in 29 patients (55.8 %; 95 % CI: 42.3–69.3 %) and 58 treatment sites (60.4 %; 95 % CI: 50.6–70.2 %). StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings. • The safety of StrataGraft remained consistent with the prescribing information. • StrataGraft showed clinical benefit in adults with deep partial-thickness burns. • Use of StrataGraft in adults with deep partial-thickness burns spared donor sites. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
03054179
Volume :
50
Issue :
8
Database :
Academic Search Index
Journal :
Burns (03054179)
Publication Type :
Academic Journal
Accession number :
180297179
Full Text :
https://doi.org/10.1016/j.burns.2024.05.023