FDA approves Stratagraft for thermal burn treatment in adult patients

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Date: 22.06.2021

The U.S. Food and Drug Administration 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).

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.

The effectiveness and safety of StrataGraft are based on two randomized clinical studies involving a total of 101 adult patients with deep partial thickness thermal burns. In both studies, two deep partial-thickness burn wounds of comparable area and depth on each patient were identified and randomized to receive either a single topical application of StrataGraft or autograft. The effectiveness is demonstrated by the percentage of StrataGraft treatment sites that achieved a complete wound closure, and the significantly decreased need for autografts at the StrataGraft treatment sites.

Based on: NewsMedical

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