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

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.

Conditions

Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound

Study Overview

Study Details

Study overview

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.

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

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

Condition
Burn
Intervention / Treatment

-

Contacts and Locations

Phoenix

Valleywise Health, Phoenix, Arizona, United States, 85008

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avita Medical,

Study Record Dates

2026-01