Intact Fish Skin Graft for Second Degree Burns

(LOGI Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kerecis Ltd.

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Fish allergy, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Adults with deep partial-thickness burns covering 3-49% of their body, who need skin grafting and have healthy skin available for potential autografting. Participants should be able to consent and start treatment within 14 days of injury.

Inclusion Criteria

My doctor believes the area where my tissue was taken will heal on its own.

I started treatment within 14 days of my injury.

I can sign the consent form myself or have someone legally authorized to do so.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn

1 month

Multiple visits for treatment application and assessment

Follow-up

Participants are monitored for wound closure, pain, and cosmesis

12 months

Regular follow-up visits, including assessments at 1 week, 2 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Autograft
• Intact Fish Skin Graft

Trial Overview

This study tests if Kerecis Intact Fish Skin Graft (IFSG) reduces the need for traditional skin grafts (autografts) in burn patients. It compares wound closure, pain levels, cosmetic outcomes between IFSG-treated sites and autografted areas over time.

How Is the Trial Designed?

Group I: IFSG-Treated Area of Burn Experimental Treatment 1 Intervention

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

Group II: SOC Autograft-Treated Area of Burn Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kerecis Ltd.

Lead Sponsor

Trials

14

Recruited

2,200+

American Burn Association

Collaborator

Trials

11

Recruited

2,200+

BData, Inc.

Collaborator