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

Study acronym: LOGI
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07326657
Lead Sponsor Kerecis Ltd.
Collaborators: American Burn Association, BData, Inc.
Conditions
(from sponsor)
Partial-thickness Burn Wounds
Related terms Burns, Ichthyosis Vulgaris
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov