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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Wound; Burn; Trauma Wound; Full Thickness Wounds
• Intervention / Treatment: Device: Cohealyx

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • ValleyWise Health
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Univ of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Health
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network
    • Lubbock, Texas, United States, 79430
      • Texas Tech University
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohealyx; Cohealyx application post surgical excision	Device: Cohealyx; Cohealyx application, followed by autologous split-thickness skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for Cohealyx to generate tissue capable of supporting definitive closure	Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft	Up to 30 days

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): February 10, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: burn, wounds, trauma wound; full thickness wounds, full thickness burns, chronic wounds, surgical wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Burns
• Other Study ID Numbers: CTP011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes