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?

This trial tests a new treatment for deep partial-thickness burns using a graft made from intact fish skin. Researchers aim to determine if this fish skin graft can reduce the need for autografts, improve wound healing, and decrease pain and scarring over time. Participants will receive both the fish skin graft and the standard autograft on different parts of their burn for comparison. This trial suits adults with burns requiring an autograft, particularly on the torso or limbs. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on systemic immunosuppressive therapy.

What is the safety track record for the Intact Fish Skin Graft?

Research has shown that Intact Fish Skin Grafts (IFSG) are safe for treating burns. Studies have found that these grafts can help wounds heal faster and reduce pain, potentially leading to fewer bandage changes and increased comfort for patients. In terms of safety, burns treated with IFSG have shown similar results to those treated with cadaver skin grafts, which are commonly used and well-accepted. Another study found that IFSGs are safe for treating various types of burns and complex wounds. As this treatment is in a late stage of research, it suggests strong evidence of safety for human use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment for second-degree burns, which typically involves autografts, the intact fish skin graft (IFSG) offers a unique approach by using fish skin as a natural graft material. This fish skin is rich in omega-3 fatty acids, which may promote healing and reduce inflammation more effectively than traditional methods. Researchers are excited about this treatment because it could potentially accelerate the healing process while being less invasive and painful compared to harvesting skin for autografts. Moreover, IFSG could offer a more readily available and cost-effective alternative to current burn treatments.

What evidence suggests that this trial's treatments could be effective for deep partial-thickness burns?

Research shows that fish skin can help heal burn wounds faster and reduce pain. In this trial, one group of participants will receive treatment with the Intact Fish Skin Graft (IFSG). Studies have found that IFSG can lower the need for extra skin grafts, often required for deep burns. Patients treated with fish skin had fewer bandage changes and experienced less discomfort. Evidence also suggests that fish skin helps wounds close better without needing additional grafts. Experts recommend fish skin as a promising option for treating burns, based on positive results in past cases. Another group in this trial will receive the standard-of-care autograft treatment for comparison. ^{1 2 3 6 7}

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

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9323726/

The Use of Acellular Fish Skin Grafts in Burn Wound ...

Existing evidence on the use of acellular fish skin indicates an acceleration of wound healing, reduction in pain and necessary dressing changes as well as ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07326657

Evaluating Whether Intact Fish Skin Graft Can Decrease ...

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

3.

mdpi.com

mdpi.com/2227-9059/12/3/680

Comparison of Intact Fish Skin Graft and Allograft as ...

FT burn wounds treated with an IFSG had similar outcome measures, including contraction rates, trans-epidermal water loss (TEWL) measurements, hydration, and ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39821348/

Intact Fish Skin Graft for the Treatment of Burns

In this article, we discuss the available products on the market for the treatment of thermal burn injuries, explore the data advocating for ...

5.

preprints.org

preprints.org/manuscript/202510.1099

Consensus Recommendations for Intact Fish Skin Graft in ...

This consensus paper presents the best to date evidence and experience-based recommendations from eight U.S. burn care experts regarding optimal ...

6.

preprints.org

preprints.org/manuscript/202510.1099/download/final_file

Consensus Recommendations for Intact Fish Skin Graft in ...

Results revealed that the burns treated with IFSG had similar outcome measures to the cadaver skin-treated burn wounds; however, the IFSG- ...

7.

oaepublish.com

oaepublish.com/articles/2347-9264.2024.54

The use of acellular fish skin grafts in burns and complex ...

FSGs represent a safe and promising product for the management of donor sites, partial-thickness and full-thickness burns, as well as complex trauma wounds.