StrataGraft is approved for treatment of deep partial-thickness thermal burns in adults, the U.S. Food and Drug Administration announced Tuesday.

StrataGraft, produced from keratinocytes and dermal fibroblasts grown together to create a cellularized scaffold, is indicated for deep partial-thickness burns, thermal burns with intact dermal elements that require surgical intervention. The FDA notes that use of StrataGraft can help reduce the amount of healthy skin needed for grafting when treating these burn wounds.

Approval was based on data from two randomized clinical studies of 101 adults with deep partial-thickness thermal burns. In both studies, researchers identified two deep partial-thickness burn wounds that were comparable in area and depth on each patient and randomly assigned the wounds to either a single topical application of StrataGraft or an autograft. Researchers found a significantly decreased need for autografts at the StrataGraft treatment sites. In the phase 3 STRATA2016 trial, 96 percent of StrataGraft-treated burn sites did not require autografting. By three months, 83 percent of patients achieved durable closure of the StrataGraft treatment site without autograft placement compared with 86 percent of patients achieving durable closure of the autograft control treatment site without additional autograft placement.

Commonly reported side effects with StrataGraft included pruritis, blisters, hypertrophic scar, and impaired healing at the treatment site. The overall safety profile of wound-related events was similar to that of autografting and included erythema, swelling, local warmth, and wound site infections. There were no reports of StrataGraft rejection.

Approval was granted to Stratatech, a Mallinckrodt company.

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