Cohealyx: Cohealyx application, followed by autologous split-thickness skin graft
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
1. The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
2. The patient is hospitalized within 3 days of injury.
3. The surgical excision occurs within 5 days post-injury.
4. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
5. 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).
6. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
1. Understand the full nature and purpose of the study, including possible risks and adverse events,
2. Understand instructions, and
3. Provide voluntary written informed consent
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for participation:
1. Clinical signs of wound infection at study area.
2. 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.
3. The patient is unable to understand English or Spanish.
4. The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
5. Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).
Primary outcome measure(s)
Time for Cohealyx to generate tissue capable of supporting definitive closure — Up to 30 days Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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