NCT06787690

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2025

Geographic Reach
1 country

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
May 2025Aug 2026

First Submitted

Initial submission to the registry

January 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

January 8, 2025

Last Update Submit

March 10, 2026

Conditions

BurnTrauma WoundFull Thickness WoundsSurgical Wound

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cohealyx

EXPERIMENTAL

Cohealyx application post surgical excision

Device: Cohealyx

Interventions

CohealyxDEVICE

Cohealyx application, followed by autologous split-thickness skin graft

Cohealyx

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Understand the full nature and purpose of the study, including possible risks and adverse events,
  • Understand instructions, and
  • Provide voluntary written informed consent

You may not qualify if:

  • Subjects who meet any of the following criteria are not eligible for participation:
  • Clinical signs of wound infection at study area.
  • 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.
  • The patient is unable to understand English or Spanish.
  • The patient has a known hypersensitivity to bovine-derived collagen, porcine, or aloe vera materials.
  • Presence of a medical condition where the patient's life expectancy is less than 1 year (e.g., malignancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Univ of Iowa

Iowa City, Iowa, 52242, United States

Location

The University of Kansas Health

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Texas Tech University

Lubbock, Texas, 79430, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

BurnsSurgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 22, 2025

Study Start

May 15, 2025

Primary Completion

February 10, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(18)