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

Running, not enrolling · Not applicable

Conditions studied: Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound

In brief

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.

Key facts

Study ID

NCT06787690

Run by

Avita Medical

People needed

41

Starts

2025-05-15

Expected to finish

2026-08-01

Last updated by the study team

2026-03-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Valleywise Health — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Univ of Iowa — Iowa City, Iowa, United States
• The University of Kansas Health — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• University Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
• University of Rochester — Rochester, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• JPS Health Network — Fort Worth, Texas, United States
• Texas Tech University — Lubbock, Texas, United States
• Chippenham Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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