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

Conditions

• Partial-thickness Burn Wounds

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intact fish skin graft — DEVICE
  Treatment with IFSG
• autograft — PROCEDURE
  Treatment with autograft

Study Details

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.

Key Dates

Start date

Jan 31, 2026

Status verified

Jan 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

65 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IFSG-Treated Area of Burn
  The area of the deep partial-thickness burn that is treated with IFSG
• Active Comparator: SOC Autograft-Treated Area of Burn
  The area of the deep partial-thickness burn that is treated with autograft as standard-of-care

Primary Outcome Measure

Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month. [ Time Frame: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later ]

Locations (1)

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