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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohealyx | Experimental | Cohealyx application post surgical excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohealyx | Device | Cohealyx application, followed by autologous split-thickness skin graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time for Cohealyx to generate tissue capable of supporting definitive closure | Defined as the number of days from placement of Cohealyx until placement of an autologous split-thickness skin graft | Up to 30 days |
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Inclusion Criteria:
Subjects must meet all the following criteria to be eligible for participation:
The patient has a staged surgical procedure planned that requires autografting for treatment of a full thickness wound.
The patient is hospitalized within 3 days of injury.
The surgical excision occurs within 5 days post-injury.
The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
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).
In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for participation:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| Valleywise Health |
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| 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 |
| ID | Term |
|---|---|
| D002056 | Burns |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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