Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thi… (NCT06787690) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyxâ„¢ is Used for Full Thickness Wounds
United States41 participantsStarted 2025-05-15
Plain-language summary
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
✓. The patient is hospitalized within 3 days of injury.
✓. The surgical excision occurs within 5 days post-injury.
✓. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
✓. The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (26 weeks post-autografting).
✓. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
✓. Understand the full nature and purpose of the study, including possible risks and adverse events,
✓. Understand instructions, and
Exclusion criteria
✕. Clinical signs of wound infection at study area.
✕. The patient has a medical condition, is using medications or receiving treatments (e.g., immune deficiency) that may compromise patient safety or the trial evaluations or objectives.
✕. The patient is unable to understand English or Spanish.
What they're measuring
1
Time for Cohealyx to generate tissue capable of supporting definitive closure