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

Kerecis

Status and phase: Invitation-only; Phase 4

Conditions: Partial-thickness Burn Wounds

Treatments: Device: Intact fish skin graft; Procedure: autograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07326657

KS-1040

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

IFSG-Treated Area of Burn

Experimental group

Description:

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

Treatment:

Device: Intact fish skin graft

SOC Autograft-Treated Area of Burn

Active Comparator group

Description:

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

Treatment:

Procedure: autograft