Kerecis Ltd.
The goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft treatment is clinically indicated. This clinical trial seeks to collect the following: 1. Difference in the percentage area of the IFSG treatment site and control autograft treatment site that required autografting within 1 month of treatment 2. Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment 3. Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment 4. Difference in the pain intensity between the IFSG treatment site and autograft treatment site Each participant will receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn. Participants will be assessed for the need for further autograft treatment. Participants will also be assessed for wound closure, pain, and cosmesis.
Inclusion Criteria: 1. At least 18 years of age at time of consent 2. Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated. 3. Be able to provide written informed consent or have a legally authorized representative 4. Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting. 5. Investigator expects that the donor site will heal without grafting 6. Have a complex skin defect of 3 to 49% Total Body Surface Area, which can consist of more than one…
Treatment with IFSG
Treatment with autograft