StrataGraft reduces need for autografts in burns
A phase 3 trial showed the majority of burns treated with StrataGraft did not require autografting and achieved durable wound closure, Mallinckrodt announced in a press release.
The multicenter, open-label pivotal STRATA2016 clinical trial found 96% of burn sites treated with StrataGraft, a viable, bioengineered, allogeneic, cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts, did not require autografting. In addition, durable wound closure was reported in 83.1% of patients by 3 months compared with 86% of those who received autograft.
Donor site pain and donor site cosmesis also had favorable results in the StrataGraft cohort.
“Surgical advances have improved survival rates in patients with severe burns. However, new treatments are needed that can help reduce or eliminate autografting, as the need to harvest healthy skin tissue can lead to pain, itching, scarring and impaired function at the donor site,” James H. Holmes IV, MD, one of the trial’s lead investigators and professor of trauma surgery at Wake Forest School of Medicine, said in the release. “We were encouraged to see in the phase 3 trial that treatment with StrataGraft eliminated donor tissue harvest in all but three of the 71 study participants. Now that StrataGraft is approved, burn surgeons have an alternative biologic treatment option for patients with deep partial-thickness burns.”