Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07326657
Eligibility Criteria:
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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07326657
Study Brief:
Protocol Section:
NCT07326657