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# StrataGraft Approved for Thermal Burns
- URL: https://www.fdaweb.com/stratagraft-approved-for-thermal-burns/
- Published: 2021-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:03:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149544

FDA has approved a Stratatech’s StrataGraft for treating adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated. StrataGraft is made from two kinds of human skin cells (keratinocytes and dermal fibroblasts) grown together to make a bi-layered construct (a cellularized scaffold), an [agency release ](https://www.fda.gov/news-events/press-announcements/fda-approves-stratagraft-treatment-adults-thermal-burns?ref=fdaweb.com)says. 

The topical application is intended to be placed onto a 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,” FDA says. “Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.”

Approval was based on data from two randomized clinical studies involving a total of 101 adult patients with deep partial-thickness thermal burns. Effectiveness was 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, FDA says.

StrataGraft was developed in conjunction with HHS’ Biomedical Advanced Research and Development Authority. “Due to StrataGraft containing cells from human donors and animal-derived materials, and because animal cells were used in early stages of product development, there is a risk of transmission of infectious diseases or agents although at this time transmission of infectious diseases or agents by StrataGraft has not been reported,” FDA says.