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New collagen patch aims to speed up wound healing for burn and trauma patients

NCT ID NCT06787690

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a product called Cohealyx, a collagen matrix placed on deep wounds after surgery to help them heal enough for a skin graft. The trial involves 41 people with full-thickness wounds from burns or trauma. Researchers want to see how long it takes for Cohealyx to prepare the wound for a successful skin graft.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cohealyx Collagen Matrix (a device applied to wounds to prepare them for skin grafting)
What this could lead to
If successful, Cohealyx could speed up wound healing and reduce the time needed before a skin graft can be placed.
What could go wrong
This is a small, early-stage study with no control group, so results may not apply broadly. The device may not work as well in all wound types or patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

May 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

burn injury Surgical Wound

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • JPS Health Network

    Fort Worth, Texas, 76104, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

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

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Texas Tech University

    Lubbock, Texas, 79430, United States

  • The University of Kansas Health

    Kansas City, Kansas, 66160, United States

  • Univ of Iowa

    Iowa City, Iowa, 52242, United States

  • University Medical Center

    New Orleans, Louisiana, 70112, United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of South Alabama

    Mobile, Alabama, 36604, United States

  • Valleywise Health

    Phoenix, Arizona, 85008, United States

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