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

NCT06625385 | Recruiting FDA Device

• 1 other identifier: EM-05-015140
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Wound

Keywords

Open; Closed

Outcome Measures

Primary Outcomes (1)

• Incidence of (ADEs)

  The incidence of adverse device effects (ADEs)

  14 days

Secondary Outcomes (4)

• Percentage of closed surgical incisions and skin flaps that remain closed

  14 days

• Percentage of skin grafts with ≥ 90% graft take

  14 days

• Percentage of open wounds with evidence of healing

  14 days

• Overall rate of wound healing for both open wounds and closed/covered wounds

  14 days

Other Outcomes (1)

• Pain score associated with dressing removal

  14 days

Study Arms (1)

3M™ V.A.C.® Peel and Place Dressing

EXPERIMENTAL

3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy

Device: 3M™ V.A.C.® Peel and Place Dressing

Interventions

3M™ V.A.C.® Peel and Place Dressing DEVICE

Application of 3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy

3M™ V.A.C.® Peel and Place Dressing

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Solventum US LLC: lead

Study Sites (3)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Stephanie Karwedsky

  Solventum

  STUDY DIRECTOR

Central Study Contacts

Eric Synatschk

CONTACT

346-550-5698; esynatschk@solventum.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 3, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)