Case report: denovoSkin™ used under compassionate use in pediatric reconstructive burn surgery

The abstract published in the Journal of Burn Care & Research (March/April 2025) by the American Burn Association (57th annual meeting) describes the compassionate use of denovoSkin™ in reconstructive surgery for a three-year-old child with 90% total body surface area (TBSA) burn injuries at Massachusetts General Hospital, a leading U.S. burn center.

The treatment was carried out under a compassionate use exemption from the U.S. FDA.

The case involved contracture release surgeries and treatment of non-healed wounds and unstable scars. The denovoSkin™ grafts demonstrated an engraftment rate greater than 95%, with the resulting skin described as durable and manageable, comparable to traditional full-thickness autografts but with advantages over conventional cultured epidermal autografts (CEAs).

The authors conclude that this use of denovoSkin™ introduces a new treatment paradigm in both acute and reconstructive burn surgery, especially for patients with extensive injuries and limited donor skin.

This case report adds to the growing body of clinical experience supporting denovoSkin™ as a potential breakthrough in skin tissue therapy, including in pediatric reconstructive care under extreme conditions. As the paper’s authors note: “The development of an autologous, full-thickness skin replacement remains the holy grail for the treatment of full thickness skin loss from burns, wounds, and trauma.”

The abstract can be read online here: Burn Care & Research 

Full citation: Matthew Supple, Robert Sheridan, Jeremy Goverman, 846 Pediatric Compassionate Use of a Novel, Autologous, Engineered, Hydrogel Skin Graft with Keratinocytes and Fibroblasts, Journal of Burn Care & Research, Volume 46, Issue Supplement_1, March/April 2025, Page S288.

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