Publications by authors named "J M Smiell"
Background: 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.
Methods: 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).
Article Synopsis
- The analysis pooled safety data from two clinical trials (NCT01437852; NCT03005106) to evaluate StrataGraft's safety and efficacy in patients with deep partial-thickness burns.
- A total of 101 adult patients were enrolled, with 86.1% experiencing adverse events; the most common were pruritus and blisters.
- The study concluded that StrataGraft is well tolerated and presents a safety profile comparable to autografts, suggesting it may be a safe alternative for treating DPT burns.
Objective: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns.
Methods: Patients aged ≥18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000cm total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft.
Reducing the amount of donor skin needed for definitive wound closure can improve outcomes in patients with severe burns. This Delphi Consensus Panel (DCP) aimed to achieve expert consensus on the percentage reduction in donor skin for autograft that constitutes a clinically meaningful benefit. A two-round DCP of fifteen US burn surgeons was conducted via a web-based survey platform.
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