By InvitationPhase 4

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

United States65 participantsStarted 2026-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.

Timeframe: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later

Trial details

NCT IDNCT07326657

SponsorKerecis Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

View on ClinicalTrials.gov More Partial-thickness Burn Wounds trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. Have thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria