Fish skin could help burn victims heal with less pain
NCT ID NCT07326657
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a special fish skin graft can help deep burn wounds heal without needing as much skin taken from the patient's own body. About 65 adults with deep partial-thickness burns will receive both the fish skin graft and a standard skin graft on different burn areas. Researchers will compare how much extra skin grafting is needed, how quickly wounds close, pain levels, and scar appearance over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intact fish skin graft (device)
- What this could lead to
- If successful, this could reduce the amount of skin patients need taken from their own body to treat burns, leading to less pain and better scarring.
- What could go wrong
- This is a small, early-phase trial with only 65 participants, so results may not apply to everyone. The fish skin graft might not work as well as standard treatment for some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Loyola University Medical Center
Maywood, Illinois, 60153, United States