FDA Gives New Burn Treatment the Green Light

FDA approves StrataGraft to treat deep partial thickness thermal burns

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment for burns.

This new treatment is called StrataGraft. The FDA approved it to treat deep partial thickness burns in adults.

Deep partial thickness burns are serious burns caused by contact with an external source of heat, such as fire, boiling water or steam. Although they are deep burns, these kind of burns leave the deeper layers of the skin intact.

Surgery is usually called for with deep partial thickness burns, but StrataGraft may offer an alternative.

“Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin," said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. "The goal of burn management is to help the patient return to the highest level of functionality and independence possible, while improving the overall quality of life. This approval provides health care professionals a novel way to treat burn wounds.”

Serious burns are usually treated with a skin graft. In this procedure, a surgeon takes healthy skin from another part of the body and grafts it over the burn wound. This process can help the burn to heal properly, but it causes a new wound on the part of the body from which the healthy skin was taken.

StrataGraft is made from human skin cells. After a health care provider places it on the burn wound, it provides a sort of scaffolding for new, healthy skin cells to grow over the wound. According to the FDA, this treatment can remove the need for a skin graft entirely or at least reduce the amount of skin necessary for a skin graft.

The FDA approved StrataGraft based on the results of two trials involving 101 patients with deep partial thickness burns. On each patient, one burn wound was treated wth StrataGraft and another was treated with a skin graft. StrataGraft appeared to close the wounds completely or reduce the amount of skin needed in a later skin graft.

Side effects of StrataGraft included blisters, itching, scarring and slowed healing. The FDA noted that the overall safety profile of StrataGraft was similar to that of a traditional skin graft. In the two clinical trials, none of the patients' bodies rejected StrataGraft.

The FDA approved StrataGraft for Stratatech, a Mallinckrodt company.

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Review Date: 
June 25, 2021