ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-15
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06787690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
  2. 2. The patient is hospitalized within 3 days of injury.
  3. 3. The surgical excision occurs within 5 days post-injury.
  4. 4. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
  5. 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. 6. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
  7. 1. Understand the full nature and purpose of the study, including possible risks and adverse events,
  8. 2. Understand instructions, and
  9. 3. Provide voluntary written informed consent
  1. 1. Clinical signs of wound infection at study area.
  2. 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. 3. The patient is unable to understand English or Spanish.
  4. 4. The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
  5. 5. Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Avita Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Burn
  • Trauma Wound
  • Full Thickness Wounds
  • Surgical Wound