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

Last updated: January 23, 2025
Sponsor: Solventum US LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

3M™ V.A.C.® Peel and Place Dressing

Clinical Study ID

NCT06625385
EM-05-015140
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 informedconsent.

  3. Subject has a wound deemed appropriate for treatment with a V.A.C.® Peel and Placedressing (used in conjunction with 3M™ V.A.C.® Therapy), according to theinstructions for use for the dressing, including the following wound types:

  • an open wound: acute/traumatic wound, dehisced surgical wound within 30 days ofsurgery, burn, venous ulcer, diabetic ulcer, or pressure ulcer Note: Prior toinitial placement, the wound may be debrided, as clinically indicated

  • a closed or covered wound secured with sutures or staples: closed surgicalincision, skin flap closure, or skin graft (recipient site)

  1. Subject is willing and able to attend all study visits.

Exclusion

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, tuballigation, hysterectomy, or oophorectomy) or are post-menopausal, defined as nothaving menstruation for > 12 months will not be required to undergo pregnancytesting.

  1. Subject is participating in another interventional clinical study or was enrolled ina clinical trial within the last 30 days before screening.

  2. Subject has been diagnosed with a malignancy in the wound.

  3. Subject has untreated osteomyelitis or untreated cellulitis in the wound.

  4. Subject has an untreated systemic infection.

  5. Subject has active cellulitis in the peri-wound area.

  6. Subject has a known allergy or hypersensitivity to study materials: dressing(s),and/or dressing components such as acrylic or silicone adhesives or polyurethane.

  7. Subject has, in the opinion of the investigator, a clinically significant conditionthat would impair the Subject's ability to comply with the study procedures or wouldcompromise assessment of endpoints (wound/peri-wound condition).

  8. Subject has had radiation directly to the wound area.

  9. Subject received hyperbaric oxygen therapy within 30 days before the initialapplication of a V.A.C.® Peel and Place dressing.

  10. Subject has been diagnosed with a major vascular deficit limiting arterial inflowinto the wound region, as determined by the investigator's interpretation of thesubject's medical history.

  11. 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 fromthe study if they meet any of the following criteria

  1. Wound has necrotic tissue and/or eschar present. NOTE: After debridement of necrotictissue and complete removal of eschar, the V.A.C.® Peel and Place dressings may beused.

  2. Wound contains a non-enteric or unexplored fistula(s) in the wound bed. 3. Wound hastunneling. 4. Wound has undermining that is ≥ 2 cm in any direction from the woundedge. 5. Wound site has inadequate hemostasis, as determined by the investigator. 6.Wound has exposed vessels, anastomotic sites, organs, or nerves that cannot beprotected prior to placement of the V.A.C.® Peel and Place Dressings.

  3. Wound has a depth greater than 2 cm (for small dressings), 4 cm (for medium dressingsize), or 6 cm (for the large dressing size).

  4. The wound received, within 30 days before initiating V.A.C.® Therapy, treatment withany of the following:

  • any previous negative pressure wound therapy device.

  • growth factors.

  • bioengineered tissue products, eg, skin or dermal substitutes. 9. Wound was closedwith tissue adhesive. 10. Wound has, in the opinion of the Investigator, anycharacteristic that would make it unsuitable for the study.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: 3M™ V.A.C.® Peel and Place Dressing
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
May 31, 2026

Study Description

This is a prospective, post-market, multi-center, single-arm study. A target of 90 enrolled Subjects with 1 enrolled study wound per Subject is planned for this study, including 60 open wounds (10 for each type of open wound) and 30 closed or covered wounds (10 for each type of closed/covered wound). The entire duration of the study is expected to last approximately 2 years. Individual Subject participation is expected to last up to 20 days, including a screening period lasting up to 5 days, the day of initial treatment, dressing change visits as clinically appropriate but no more than 7 days from dressing application, and an end-of-treatment (EOT)/end-of-study (EOS) visit between Day 7 and Day 14 after the initial dressing application.

Connect with a study center

  • IU Health Methodist Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Washington University - Barnes Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

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