Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds

This is a prospective single-arm post-market multicenter study to evaluate clinical outcomes of Cohealyx when used to manage full thickness wounds post-surgical excision. A systematic literature review and meta-analysis were conducted to establish a performance goal for the primary effectiveness endpoint (time to autografting).

Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury.

Following placement of Cohealyx, investigators will evaluate the wound every 3 days. Once Cohealyx has successfully integrated into the wound bed, as indicated by a robust vascularized tissue bed, the wound bed will be prepared and autografted per the investigative site's standard of care.

The study area will be evaluated with respect to Cohealyx integration, time to autografting, autograft take, healing, and safety-related adverse events.

Post-autografting, subjects will be followed for 6.5 months. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas as well as any donor sites dressed in PermeaDerm will be documented using digital photography.

Inclusion criteria

Subjects must meet all the following criteria to be eligible for participation:

• 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
• Provide voluntary written informed consent

Exclusion criteria

Subjects who meet any of the following criteria are not eligible for participation:

• 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.
• The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
• Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).