Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns
Condition(s) studied
Investigational drug(s) / intervention(s)
Intact fish skin graft: Treatment with IFSG
autograft: Treatment with autograft
Study summary
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.
Eligibility
Primary outcome measure(s)
- Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month. — From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois |
More Kerecis Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07326657 on ClinicalTrials.gov ↗ ← All trials in the USA