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

NCT07326657 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-08

No results posted yet for this 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.

Conditions

  • Partial-thickness Burn Wounds

Interventions

DEVICE

Intact fish skin graft

Treatment with IFSG

PROCEDURE

autograft

Treatment with autograft

Sponsors & Collaborators

  • American Burn Association

    collaborator OTHER

  • BData, Inc.

    collaborator UNKNOWN

  • Kerecis Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326657 on ClinicalTrials.gov