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New dressing may cut costs for skin graft patients

NCT ID NCT06750809

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new temporary dressing called PermeaDerm with a standard one (Allograft) for people who need a skin graft after surgery or injury. About 40 participants will have the dressing applied to their wound, then a skin graft a few days later. Researchers will check costs, how well the dressing sticks, wound healing, and complications over about 8 weeks.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

May 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's wound requires temporary dressing coverage after surgical excision and prior to autografting. 2. The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA). 3. The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization. 4. The patient is hospitalized within 3 days of injury. 5. The surgical excision occurs within 5 days post-injury. 6. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule. 7. 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 (8 weeks post-autografting). 8. 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. The study area has received prior surgical intervention. 2. The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives. 3. Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives. 4. The patient has any of the following 1. morbid obesity (BMI \>40), 2. immunodeficiency, 3. venous insufficiency/PVD of the lower extremities (when study area is also in this location), 4. chronic malnourishment, 5. inhalation injury (\>Grade 1 based on AIS grading scale), 6. current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results, 7. diabetes mellitus with HbA1c \>9.0%, and/or 8. advanced renal disease (eGFR \<59) or liver disease (LFTs \>2.5 times the upper limit). 5. The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives. 6. The patient is unable to understand English or Spanish. 7. The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft. 8. The patient's life expectancy is less than 1 year. \-

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Conditions

The condition(s) this trial relates to.

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

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Grady Memorial

    Atlanta, Georgia, 30303, United States

  • Medstar Washington Hospital Center

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

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Regional One Firefighter's Burn Center

    Memphis, Tennessee, 38163, United States

  • Univ of Iowa

    Iowa City, Iowa, 52242, United States

  • Univ of Louisville Burn Center

    Louisville, Kentucky, 40202, United States

  • University Medical Center

    New Orleans, Louisiana, 70112, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • Valleywise Health

    Phoenix, Arizona, 85008, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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