NCT07326657

Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns

Open-label, Controlled, Randomized, Multicenter Study Evaluating Intact Fish Skin Graft in Promoting AutoLOgous Skin Tissue ReGeneratIon of Deep Partial-Thickness Burns: The LOGI Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Kerecis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial-thickness Burn Wounds

Interventions

Type	Name	Description
DEVICE	Intact fish skin graft	Treatment with IFSG
PROCEDURE	autograft	Treatment with autograft

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study