29 Sep With new study results, Stratatech to seek federal approval for its skin tissue for burn treatment
Burn wounds treated in a clinical trial with skin tissue made by the Madison company Stratatech mostly healed well and rarely required patient skin grafts, findings that will spur an application for federal approval next year, the company said last week.
Stratatech, bought in 2016 for $76 million by England-based Mallinckrodt Pharmaceuticals, makes StrataGraft, a regenerative tissue using human cells derived from discarded foreskins after circumcision. The goal is to prevent or reduce the need to use painful autografts, or skin grafts from a patient’s own body, to cover up burn wounds and help them heal.
In a phase 3 study at 12 burn centers, 71 patients with deep second-degree burns received StrataGraft on one area of a burn injury and an autograft on a similarly burned site.
After three months, 83% of burn wounds treated with StrataGraft tissue were closed, compared to 86% of wounds treated with autografts, Mallinckrodt said.
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