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

January 7, 2026 updated by: Kerecis Ltd.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years of age at time of consent
  2. Must have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated.
  3. Be able to provide written informed consent or have a legally authorized representative
  4. Have sufficient healthy skin identified and designated as a potential donor site in the event that the IFSG treatment site requires autografting.
  5. Investigator expects that the donor site will heal without grafting

  6. 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:

  7. Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
  8. Study treatment areas can be up to 2000 cm2
  9. 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
  10. 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)
  11. Have first excision and grafting of study treatment sites
  12. Have thermal burn(s) on the torso or extremities

Exclusion Criteria:

  1. Known allergy or hypersensitivity to fish (shellfish allergy is OK)
  2. Female who is actively pregnant or currently breast-feeding
  3. Vulnerable populations
  4. Currently receiving systemic immunosuppressive therapy
  5. Current or known history of malignancy or receipt of chemotherapy
  6. History of Diabetes with documented uncontrolled diabetes (as defined by an A1C >9) within the last 6 months
  7. Have an expected survival of less than 3 months
  8. Are currently participating/have participated in the treatment group of an interventional study within 90 calendar days prior to consent

  9. Have other wounds present for > 30 days

    At the time of debridement:

  10. Treatment area is assessed as full-thickness after debridement
  11. 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)

  12. Have a clinical or laboratory determination of infection at the anticipated treatment sites.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IFSG-Treated Area of Burn
The area of the deep partial-thickness burn that is treated with IFSG
Device: Intact fish skin graft
Treatment 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
Procedure: autograft
Treatment with autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement
Time Frame: From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later
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
Time Frame: From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) that describes scar quality on a scale from 1-10 with 1 being a scar very similar to normal skin and 10 being a severe scar very unlike normal skin.
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)
Time Frame: From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later
The Wong-Baker FACES pain rating scale presents a range of faces with a happy face associated with a score of 0, meaning "no hurt", to a very sad face associated with a score of 10, meaning "hurts worst."
From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kerecis Ltd.

Collaborators

American Burn Association
BData, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS-1040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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