Back to Search
Start Over
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.
- 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