Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts 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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohealyx
Cohealyx application post surgical excision
  • Device: Cohealyx
    Cohealyx application, followed by autologous split-thickness skin graft

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Matthew Supple
617-726-3712
mdsupple@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Avita Medical

Study Contact

Elizabeth Kirshner
833-462-8482
ekirshner@avitamedical.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.