Evaluating the 3M V.A.C. Peel and Place Dressing for Wound Treatment

A Post-market, Prospective, Multi-center, Single-arm Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing Used in Conjunction With 3M™ V.A.C.® Therapy

This study is testing if the 3M V.A.C. Peel and Place dressing helps people with different types of wounds heal better when used with 3M V.A.C. Therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Solventum US LLC (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Indianapolis, Indiana and 2 other locations)
• Trial ID: NCT06625385 on ClinicalTrials.gov

What this trial studies

This clinical study aims to gather post-market safety and efficacy data for the 3M V.A.C. Peel and Place dressing used alongside 3M V.A.C. Therapy. It is a prospective, multi-center, single-arm study targeting 90 subjects with various types of wounds, including both open and closed wounds. Participants will be monitored over a period of up to 20 days, with dressing changes and follow-up visits scheduled as needed. The study will assess the effectiveness of the dressing in promoting wound healing and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 22 and older with appropriate open or closed wounds suitable for treatment with the V.A.C. dressing.

Not a fit: Patients who are pregnant or lactating, or those with wounds not suitable for the V.A.C. dressing will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance wound healing processes and improve patient care for those with specific wound types.

How similar studies have performed: Previous studies have shown positive outcomes with similar wound treatment approaches, indicating potential for success in this study.

Eligibility criteria

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.

Where this trial is running

Indianapolis, Indiana and 2 other locations

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

Study contacts

• Study coordinator: Eric Synatschk

Conditions Wound; Open; Closed