The U.S. Food Drug and Administration (U.S. FDA) has reportedly sanctioned the use of StrataGraft in adult patients to treat thermal burns with intact dermal elements for which surgical intervention is required. StrataGraft is a novel medication developed by U.S-based Stratatech- a Mallinckrodt entity.
Notably, thermal burns are caused due to direct contact with any external sources of heat like hot surfaces, scalding water, steam, or fire.
According to Peter Marls, M.D., Ph.D., Director of Center for Biologics Evaluation and Research at FDA, incidences of serious burns can be difficult to treat and may adversely affect more than the skin. Burn management aims at helping the patient achieve the highest level of functionality while enhancing overall quality of life.
The treatment for most deep burns include the removal of burned, damaged skin along with its replacement with a skin graft. Skin grafts are usually a patch of patient’s healthy skin taken from parts of their body which is then used in the burnt area to help it heal. Also known as autograft, this procedure leaves a wound where the healthy skin has been removed from.
Citing sources, StrataGraft has been developed from two types of human skin cells namely- dermal fibroblasts and keratinocytes, that are grown together to create a bi-layered construct.
For the record, StrataGraft is to be used for topic application by placing it onto the burn by a healthcare expert. With time, the patient’s skin cells grow to replace the cells that were lost due to the burn. The use of StrataGraft can help decrease or eliminate the amount of healthy skin which is required for grafting.
Developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, the efficacy and safety of StrataGraft is based on two clinical trials that involved 101 adult patients suffering from deep partial-thickness thermal burns.