Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
NCT ID: NCT06787690
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
41 participants
INTERVENTIONAL
2025-05-15
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohealyx
Cohealyx application post surgical excision
Cohealyx
Cohealyx application, followed by autologous split-thickness skin graft
Interventions
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Cohealyx
Cohealyx application, followed by autologous split-thickness skin graft
Eligibility Criteria
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Inclusion Criteria
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
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).
ALL
No
Sponsors
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Avita Medical
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CTP011
Identifier Type: -
Identifier Source: org_study_id
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