StrataGraft Skin Tissue Expanded Access at Specific Study Sites

An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue is an investigational tissue that can be used as an alternative to an autograft. - StrataGraft skin tissue is in late stage clinical development for deep partial-thickness burns. - There have been no safety concerns reported to date The sponsor submitted a treatment protocol to FDA for experienced doctors to keep using StrataGraft before it is marketed (expanded access), so the product is available (by invitation only at the locations listed). The main purpose of the study is to allow patients to receive StrataGraft prior to approval by the Food and Drug Administration for the treatment of deep partial-thickness burns. The primary outcome measure will be the number of participants with adverse events and safety concerns.

The primary purpose of this trial is to provide expanded access to StrataGraft for thermally induced deep partial-thickness burns that contain intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.