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Enrolling by Invitation

NCT Number: NCT07326657

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

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.

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Key information

Conditions

Partial-thickness Burn Wounds Burns Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Ichthyosis Ichthyosis Vulgaris Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

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Treatment and study plan

Intact fish skin graft

Device

Treatment with IFSG

Autograft

Procedure

Treatment with autograft

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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."

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Collaborators

  • American Burn Association
  • BData, Inc.

Registry information

Official study title

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

Acronym: LOGI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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