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Clinical Trials in the USA / NCT06787690
Active, not recruiting Not applicable

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

NCT06787690 · tracked via the Priya Life Science USA tracker
Sponsor
Avita Medical
Phase
Not applicable
Started
2025-05-15
Last updated
2026-03-12

Condition(s) studied

BurnTrauma WoundFull Thickness WoundsSurgical Wound

Investigational drug(s) / intervention(s)

Cohealyx

Cohealyx: Cohealyx application, followed by autologous split-thickness skin graft

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

Sex
ALL
Min age
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
University of South Alabama Mobile Alabama
Valleywise Health Phoenix Arizona
University of Arizona Tucson Arizona
Medstar Washington Hospital Center Washington D.C. District of Columbia
Univ of Iowa Iowa City Iowa
The University of Kansas Health Kansas City Kansas
University of Louisville Louisville Kentucky
University Medical Center New Orleans Louisiana
Massachusetts General Hospital Boston Massachusetts
Mercy Hospital Springfield Springfield Missouri
University Medical Center of Southern Nevada Las Vegas Nevada
University of Rochester Rochester New York
Akron Children's Hospital Akron Ohio
Ohio State University Columbus Ohio
Medical University of South Carolina Charleston South Carolina
JPS Health Network Fort Worth Texas
Texas Tech University Lubbock Texas
Chippenham Hospital Richmond Virginia

More Avita Medical trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06787690 on ClinicalTrials.gov ↗ ← All trials in the USA