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June 15, 2021StrataGraft Approved to Treat Thermal Burns
June 15, 2021 – The U.S. FDA has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat), manufactured by Mallinckrodt, to treat adults who have thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated. These burns are also referred to as deep partial thickness burns.
When skin touches an external heat source like fire, steam, scalding water, and hot surfaces, this can cause a thermal burn. Approximately 40,000 people require hospitalization for severe burns each year in the United States. Serious burns can be difficult to treat and have significant consequences such as severe scarring and long-term disability. Often, the treatment for deep partial thickness burns consists of surgery to remove dead and damaged tissue and apply autografts. An autograft is a skin graft performed by removing healthy skin from one part of a patient’s body and transplanting it to the burn area. While this can help heal the burn site, it creates an additional wound to manage where the healthy skin was removed.
StrataGraft is a bioengineered product made of keratinocytes and dermal fibroblasts (two types of skin cells) that secrete growth factors and cytokines to aid in tissue regeneration and wound healing. In a clinical trial, 96% of burn sites treated with StrataGraft did not require autografting. Eighty-three percent of patients treated with StrataGraft achieved durable closure of the burn site at three months without autografting, while 86% of patients treated with autograft achieved durable closure at three months without any additional autografting needed.
Under the recommended dosing, a healthcare professional applies StrataGraft to the burn site under aseptic conditions in a suitable surgical environment. The surface area of the StrataGraft should be equal to the surface area of the wound to be treated, and multiple sheets of StrataGraft may be required.
Launch and pricing information are not yet available.