FDA Approves New Skin Graft for Thermal Burns

The FDA announced approval of a new bioengineered allogeneic cellularized construct (BACC) for the treatment of deep partial-thickness thermal burns. Deep partial-thickness burns contain intact dermal elements and are clinically indicated for surgical intervention.

The approval comes after demonstrated effectiveness and safety in two randomized clinical studies involving 101 adult patients with deep partial-thickness thermal burns, as caused by direct contact with an external heat source such as steam, scalding water, hot surfaces, or fire. In the studies, two burn wounds of comparable area and depth after excision were identified on each patient and were randomized to receive either a single BACC application or autograft.

Overall, burn wounds that received the BACC showed comparable wound closure rates to those than received autograft application in the trials. The BACC also significantly decreased need for autografts after 3 months at BACC-treatment sites. Safety was comparable to autografting, and common side effects reported by patients included pruritus, blisters, hypertrophic scarring, and impaired healing.

The BAAC is an allogeneic produced from human keratinocytes and dermal fibroblasts, which are grown together in murine collagen-dsat to create a bilayered cellularized scaffold.

Reference
FDA approves StrataGraft for the treatment of adults with thermal burns. Press release. US Food and Drug Administration. Published June 15, 2021. Accessed June 16, 2021. https://www.prnewswire.com/news-releases/fda-approves-stratagraft-for-the-treatment-of-adults-with-thermal-burns-301313055.html