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

Last updated: March 10, 2026
Sponsor: Avita Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pressure Ulcer

Pressure Ulcers

Skin Wounds

Treatment

Cohealyx

Clinical Study ID

NCT06787690
CTP011
  • All Genders

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 Criteria

Inclusion

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 fortreatment 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 andable to comply with all study procedures and visit schedule.

  5. The patient (or parent/guardian/legally authorized representative) agrees to abstainfrom any other treatment of the study area or enrollment in another interventionalclinical trial for the duration of his/her participation in the study (26 weekspost-autografting).

  6. In the opinion of the investigator, the patient (or parent/guardian/legallyauthorized representative) must be able to:

  7. Understand the full nature and purpose of the study, including possible risksand adverse events,

  8. Understand instructions, and

  9. Provide voluntary written informed consent

Exclusion

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 trialevaluations or objectives.

  3. The patient is unable to understand English or Spanish.

  4. The patient has a known hypersensitivity to bovine-derived collagen, porcine, oraloe vera materials.

  5. Presence of a medical condition where the patient's life expectancy is less than 1year (e.g., malignancy).

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Cohealyx
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
August 31, 2026

Study Description

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.

Connect with a study center

  • University of South Alabama

    Mobile, Alabama 36604
    United States

    Site Not Available

  • University of South Alabama

    Mobile 4076598, Alabama 4829764 36604
    United States

    Site Not Available

  • Valleywise Health

    Phoenix, Arizona 85008
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Valleywise Health

    Phoenix 5308655, Arizona 5551752 85008
    United States

    Site Not Available

  • University of Arizona

    Tucson 5318313, Arizona 5551752 85724
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Univ of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Univ of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • The University of Kansas Health

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • The University of Kansas Health

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • University Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University Medical Center

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Mercy Hospital Springfield

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Mercy Hospital Springfield

    Springfield 4409896, Missouri 4398678 65804
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Rochester

    Rochester 5134086, New York 5128638 14642
    United States

    Site Not Available

  • Akron Children's Hospital

    Akron, Ohio 44308
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Akron Children's Hospital

    Akron 5145476, Ohio 5165418 44308
    United States

    Site Not Available

  • Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • JPS Health Network

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Tech University

    Lubbock, Texas 79430
    United States

    Site Not Available

  • JPS Health Network

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Texas Tech University

    Lubbock 5525577, Texas 4736286 79430
    United States

    Site Not Available

  • Chippenham Hospital

    Richmond, Virginia 23225
    United States

    Site Not Available

  • Chippenham Hospital

    Richmond 4781708, Virginia 6254928 23225
    United States

    Site Not Available

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