RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-20

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06625385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: acute/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.	1. Subject is pregnant or lactating prior to application of the initial dressing. \* 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.

Inclusion Criteria

Exclusion 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: acute/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.

1. Subject is pregnant or lactating prior to application of the initial dressing. \*
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.

Contacts and Locations

Study Contact

Eric Synatschk

CONTACT

346-550-5698

esynatschk@solventum.com

Principal Investigator

Sher-ree Beekman

STUDY_DIRECTOR

Solventum

Study Locations (Sites)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202

United States

Washington University - Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015

United States

Collaborators and Investigators

Sponsor: Solventum US LLC

Sher-ree Beekman, STUDY_DIRECTOR, Solventum

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-01-20

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Open
Closed

Additional Relevant MeSH Terms

Wound