New dressing aims to boost wound healing in Real-World study

NCT ID NCT06625385

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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.

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how safe and effective a special dressing (3M V.A.C. Peel and Place) is when used with a standard wound vacuum therapy. About 90 adults with open wounds or surgical incisions will be treated and monitored. The goal is to see if the dressing helps wounds close and skin grafts heal better.

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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 90 people

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

Started

Jan 2025

Expected to finish

May 2027

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

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Subject is at least 22 years old at the time of consent. 2. Subject or legally authorized representative (LAR) is able to provide informed consent. 3. Subject has a wound deemed appropriate for treatment with a V.A.C.® Peel and Place dressing (used in conjunction with 3M™ V.A.C.® Therapy), according to the instructions for use for the dressing, including the following wound types: * an open wound: traumatic wound, dehisced surgical wound within 30 days of surgery, burn, venous ulcer, diabetic ulcer, or pressure ulcer Note: Prior to initial placement, the wound may be debrided, as clinically indicated * a closed or covered wound secured with sutures or staples: closed surgical incision, skin flap closure, or skin graft (recipient site) 4. Subject is willing and able to attend all study visits. Exclusion Criteria: 1. Subject is pregnant or lactating prior to application of the initial dressing. \* \*Women who have had surgical sterilization by a medically accepted method (ie, tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for \> 12 months will not be required to undergo pregnancy testing. 2. Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening. 3. Subject has been diagnosed with a malignancy in the wound. 4. Subject has untreated osteomyelitis or untreated cellulitis in the wound. 5. Subject has an untreated systemic infection. 6. Subject has active cellulitis in the peri-wound area. 7. Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane. 8. Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures or would compromise assessment of endpoints (wound/peri-wound condition). 9. Subject has had radiation directly to the wound area. 10. Subject received hyperbaric oxygen therapy within 30 days before the initial application of a V.A.C.® Peel and Place dressing. 11. Subject has been diagnosed with a major vascular deficit limiting arterial inflow into the wound region, as determined by the investigator's interpretation of the subject's medical history. 12. In the case of a lower extremity wound, the Subject has one of the following: * an ankle brachial index \< 0.8; * no palpable pulse; or * no discernable audio Doppler signal. Individual wounds are to be excluded from the study if they meet any of the following criteria 1. Wound has necrotic tissue and/or eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, the V.A.C.® Peel and Place dressings may be used. 2. Wound contains a non-enteric or unexplored fistula(s) in the wound bed. 3. Wound has tunneling. 4. Wound has undermining that is ≥ 2 cm in any direction from the wound edge. 5. Wound site has inadequate hemostasis, as determined by the investigator. 6. Wound has exposed vessels, anastomotic sites, organs, or nerves that cannot be protected prior to placement of the V.A.C.® Peel and Place Dressings. 7. Wound has a depth greater than 2 cm (for small dressings), 4 cm (for medium dressing size), or 6 cm (for the large dressing size). 8. The wound received, within 30 days before initiating V.A.C.® Therapy, treatment with any of the following: * any previous negative pressure wound therapy device. * growth factors. * bioengineered tissue products, eg, skin or dermal substitutes. 9. Wound was closed with tissue adhesive. 10. Wound has, in the opinion of the Investigator, any characteristic that would make it unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • IU Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • St. Luke's University Hospital

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • Washington University - Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.