Mallinckrodt Enrolls Patient In Trial Of StrataGraft Regenerative Skin Tissue

(RTTNews) - Mallinckrodt plc (MNK) confirmed enrollment of the first patient in the company's Phase 3 study assessing the efficacy and safety of StrataGraft regenerative skin tissue in the promotion of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements.

The Phase 3 clinical study is entitled "A Phase 3 Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated."

The study will include patients with 3-49% total body surface area complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. Autograft can be defined as surgically harvesting the patient's own uninjured skin for use as a graft on the injured site.