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

Recruiting now · Not applicable

Conditions studied: Wound

In brief

The purpose of this clinical study is to obtain post-market safety and efficacy data when the V.A.C.® Peel and Place dressing is used in conjunction with 3M™ V.A.C.® Therapy.

Key facts

Study ID

NCT06625385

Run by

Solventum US LLC

People needed

90

Starts

2025-01-20

Expected to finish

2027-05-01

Last updated by the study team

2026-02-13

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is at least 22 years old at the time of consent.
• Subject or legally authorized representative (LAR) is able to provide informed consent.
• 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)
• Subject is willing and able to attend all study visits.

You may not qualify if…

• 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.
• Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
• Subject has been diagnosed with a malignancy in the wound.
• Subject has untreated osteomyelitis or untreated cellulitis in the wound.
• Subject has an untreated systemic infection.
• Subject has active cellulitis in the peri-wound area.
• Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
• 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).
• Subject has had radiation directly to the wound area.
• Subject received hyperbaric oxygen therapy within 30 days before the initial application of a V.A.C.® Peel and Place dressing.
• 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.
• 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
• 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.
• Wound contains a non-enteric or unexplored fistula(s) in the wound bed.
• Wound has tunneling.
• Wound has undermining that is ≥ 2 cm in any direction from the wound edge.
• Wound site has inadequate hemostasis, as determined by the investigator.
• 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.
• 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).
• The wound received, within 30 days before initiating V.A.C.® Therapy, treatment with any of the following:

Where it is running

• IU Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States (enrolling)
• St. Luke's University Hospital — Bethlehem, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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