The U.S. Food and Drug Administration (FDA) approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns).
Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces or fire.
For many deep burns, treatment frequently involves the removal of the damaged, burned skin and replacement with a skin graft. Skin grafts are often the patient’s own healthy skin taken from their body and moved to the burned area to help it heal. This procedure, called an autograft, leaves a new wound where the healthy skin was removed.
StrataGraft is produced from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered construct (a cellularized scaffold).
StrataGraft is for topical application, placed onto the burn by a healthcare provider. Over time, the patient’s skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.
StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
The FDA granted approval to Stratatech, a Mallinckrodt company.
