Mallinckrodt’s treatment made of artificial skin tissue called Stratagraft closed over 80% of second-degree burn wounds in a phase III trial, matching the effectiveness of skin grafts.
Mallinckrodt recruited 71 patients with second-degree burns who were eligible for skin grafts into the trial. Each patient received the artificial skin graft on some areas of burned skin, and a regular skin graft on others as a control. Three months later, the artificial skin closed 83% of the burn wounds, which was as effective as the 86% of burn wounds closed with regular skin grafts. With this evidence in hand, Mallinckrodt plans to apply for FDA approval in 2020.