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

NCT07326657 | Enrolling By Invitation Phase 4 DMC FDA Device

• 1 other identifier: KS-1040
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment
3. 3.Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment
4. 4.Difference in the pain intensity between the IFSG treatment site and autograft treatment site

Conditions

Partial-thickness Burn Wounds

Keywords

burn; deep partial-thickness; Kerecis; fish skin graft; autograft; split thickness skin graft; fish skin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement

  From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later

• Difference in cosmesis between the IFSG treatment site and autograft treatment site at Month 12 based on observer POSAS total score

  From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later

• Difference in the pain intensity between the IFSG treatment site and autograft treatment site one week after treatment based on the Wong-Baker FACES pain rating scale (FPRS)

  From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later

Study Arms (2)

IFSG-Treated Area of Burn

EXPERIMENTAL

The area of the deep partial-thickness burn that is treated with IFSG

Device: Intact fish skin graft

SOC Autograft-Treated Area of Burn

ACTIVE COMPARATOR

The area of the deep partial-thickness burn that is treated with autograft as standard-of-care

Procedure: autograft

Interventions

Intact fish skin graft DEVICE

Treatment with IFSG

IFSG-Treated Area of Burn

autograft PROCEDURE

Treatment with autograft

SOC Autograft-Treated Area of Burn

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age at time of consent
• Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated.
• Be able to provide written informed consent or have a legally authorized representative
• Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting.
• Investigator expects that the donor site will heal without grafting
• Have a complex skin defect of 3 to 49% Total Body Surface Area, which can consist of more than one contiguous area
• At the time of debridement:
• Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
• Study treatment areas can be up to 2000 cm2
• Must have at least 100 cm2 TBSA for which autografting is indicated and on which IFSG can be applied, which may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
• Application of IFSG or SOC must be initiated within 14 days of injury (Application of IFSG or SOC must be initiated within 14 days of injury)
• Have first excision and grafting of study treatment sites
• Have thermal burn(s) on the torso or extremities

You may not qualify if:

• Known allergy or hypersensitivity to fish (shellfish allergy is OK)
• Female who is actively pregnant or currently breast-feeding
• Vulnerable populations
• Currently receiving systemic immunosuppressive therapy
• Current or known history of malignancy or receipt of chemotherapy
• History of Diabetes with documented uncontrolled diabetes (as defined by an A1C \>9) within the last 6 months
• Have an expected survival of less than 3 months
• Are currently participating/have participated in the treatment group of an interventional study within 90 calendar days prior to consent
• Have other wounds present for \> 30 days
• At the time of debridement:
• Treatment area is assessed as full-thickness after debridement
• Treatment areas on the face, neck, head, hands, feet, buttocks, perineum, and areas over joints (Treatment areas may only be on the torso or extremities)
• Have a clinical or laboratory determination of infection at the anticipated treatment sites.

Sponsors & Collaborators

• Kerecis Ltd.: lead
• American Burn Association: collaborator
• BData, Inc.: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Burns; Ichthyosis Vulgaris

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The intervention study model is a split-body intervention in which each patient has part of their burn treated with intact fish skin graft and another part treated with autograft as the standard-of-care.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)