Using Cohealyx for treating full thickness wounds

A Prospective Multicenter Single-arm Clinical Study to Investigate Clinical Outcomes When Cohealyx™ is Used for the Management of Full Thickness Wounds Post-surgical Excision

This study is testing if a new collagen treatment called Cohealyx can help heal deep wounds that need skin grafts faster and more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sex: All
• Sponsor: Avita Medical (Industry-sponsored)
• Locations: 10 sites (Mobile, Alabama and 9 other locations)
• Trial ID: NCT06787690 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical outcomes of Cohealyx Collagen Matrix in managing full thickness wounds that require skin grafting after surgical excision. It is a multicenter, single-arm trial where patients will receive Cohealyx within 5 days post-injury, followed by regular evaluations every 3 days to assess integration and readiness for autografting. The primary focus is on the time taken for Cohealyx to support definitive closure of the wound. Patients will be monitored for 6.5 months post-autografting to document healing and any adverse events.

Who should consider this trial

Good fit: Ideal candidates are patients with full thickness wounds who are hospitalized within 3 days of injury and require autografting.

Not a fit: Patients with wounds that do not require autografting or those who are not hospitalized within the specified timeframe may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing times and outcomes for patients with severe wounds requiring grafts.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using collagen matrices have shown promise in wound healing.

Eligibility criteria

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).

Where this trial is running

Mobile, Alabama and 9 other locations

• University of South Alabama — Mobile, Alabama, United States (Not_yet_recruiting)
• Valleywise Health — Phoenix, Arizona, United States (Recruiting)
• University of Arizona — Tucson, Arizona, United States (Not_yet_recruiting)
• University Medical Center — New Orleans, Louisiana, United States (Not_yet_recruiting)
• University of Rochester — Rochester, New York, United States (Not_yet_recruiting)
• Akron Children's Hospital — Akron, Ohio, United States (Not_yet_recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• JPS Health Network — Fort Worth, Texas, United States (Recruiting)
• Texas Tech University — Lubbock, Texas, United States (Not_yet_recruiting)
• Chippenham Hospital — Richmond, Virginia, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Elizabeth Kirshner

Conditions Burn; Trauma Wound; Full Thickness Wounds; Surgical Wound