What is the 3M V.A.C. Peel and Place dressing studying for wound treatment?

This trial is studying the safety and effectiveness of the 3M V.A.C. Peel and Place dressing used with 3M V.A.C. Therapy for treating various types of wounds. The research aims to provide important data on how well the dressing helps wounds heal and monitors any side effects. The study is sponsored by Solventum US LLC and helps improve knowledge about this wound care device.

Who may be eligible for this wound clinical trial?

Adults aged 22 years or older with a wound suitable for treatment with the V.A.C. Peel and Place dressing may be eligible. The study accepts all genders and requires participants to be able to provide consent and attend all study visits. People who are pregnant, have certain infections, or have allergies to dressing materials may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this wound clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal expenses such as travel to and from the study site may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join the trial.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

Healthy Volunteers

ID06625385

Post-market Study of 3M V.A.C. Peel and Place Dressing with 3M V.A.C. Therapy for Treating Various Wounds in Adults

Led by Solventum US LLC · Updated on 2026-02-13

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the 3M20V.A.C.AE Peel and Place dressing when used with 3M20V.A.C.AE Therapy for treating various wound types. This study collects post-market data to better understand how well this dressing works and how safe it is for patients with open or closed wounds. The study is prospective, conducted at multiple centers, and involves a single group of participants. Participants will receive the 3M20V.A.C.AE Peel and Place dressing applied along with 3M20V.A.C.AE Therapy. The study plans to enroll about 90 subjects, each with one study wound, including 60 open wounds and 30 closed or covered wounds. Treatment includes an initial dressing application, with dressing changes as needed but no more than 7 days apart, followed by an end-of-treatment visit between 7 and 14 days after the first application. Participants will be involved for up to 20 days, beginning with a screening period up to 5 days. During the study, researchers will monitor the incidence of adverse device effects and assess wound healing, including the closure of surgical incisions and skin flaps, skin graft success, and overall wound healing rates. Safety and healing outcomes will be evaluated at 14 days, with multiple clinical visits for dressing changes and assessments.

CONDITIONS

Brief Title

A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing

Who Can Participate

Age: 22Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Subject is at least 22 years old at the time of consent.
Subject or legally authorized representative can provide informed consent.
Subject has a wound suitable for treatment with V.A.C. Peel and Place dressing with 3M V.A.C. Therapy, including open wounds (traumatic, dehisced surgical within 30 days, burn, venous ulcer, diabetic ulcer, pressure ulcer) or closed/covered wounds (closed surgical incision, skin flap closure, skin graft recipient site).
Subject is willing and able to attend all study visits.

You will not qualify if you...

Subject is pregnant or lactating prior to initial dressing application, unless surgically sterilized or post-menopausal.
Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
Subject has a malignancy diagnosed in the wound.
Subject has untreated osteomyelitis or cellulitis in the wound.
Subject has an untreated systemic infection.
Subject has active cellulitis in the peri-wound area.
Subject has known allergy or hypersensitivity to dressing materials like acrylic, silicone adhesives, or polyurethane.
Subject has any clinically significant condition impairing compliance or assessment.
Subject had radiation directly to the wound area.
Subject received hyperbaric oxygen therapy within 30 days before initial dressing.
Subject has major vascular deficits limiting blood flow to the wound.
For lower extremity wounds, subject has ankle brachial index < 0.8, no palpable pulse, or no Doppler signal.
Individual wounds with necrotic tissue or eschar (unless debrided), non-enteric fistulas, tunneling, undermining ≥ 2 cm, inadequate hemostasis, exposed vessels/organs/nerves not protected, excessive depth (over 2, 4, or 6 cm depending on dressing size), recent negative pressure wound therapy, growth factors, bioengineered tissue products, tissue adhesive closure, or unsuitable characteristics per investigator are excluded.

Research Team

Eric Synatschk

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Post-market Study of 3M V.A.C. Peel and Place Dressing with 3M V.A.C. Therapy for Treating Various Wounds in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria