Actively Recruiting
A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing
Led by Solventum US LLC · Updated on 2026-02-13
90
Participants Needed
3
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 22 years old at the time of consent.
- Subject or legally authorized representative can provide informed consent.
- Subject has a wound suitable for treatment with the V.A.C. Peel and Place dressing and 3M V.A.C. Therapy, including open wounds (traumatic, dehisced surgical within 30 days, burn, venous ulcer, diabetic ulcer, pressure ulcer) or closed/covered wounds (closed surgical incision, skin flap closure, or skin graft recipient site).
- Subject is willing and able to attend all study visits.
You will not qualify if you...
- Subject is pregnant or lactating, unless surgically sterilized or post-menopausal.
- Subject is enrolled in another interventional clinical study or was in one within 30 days prior to screening.
- Subject has malignancy in the wound.
- Subject has untreated osteomyelitis or cellulitis in the wound.
- Subject has untreated systemic infection.
- Subject has active cellulitis around the wound.
- Subject has allergy or hypersensitivity to study materials like dressing components.
- Subject has a significant condition impairing study compliance or endpoint assessment.
- Subject had radiation directly to the wound area.
- Subject received hyperbaric oxygen therapy within 30 days before dressing application.
- Subject has major vascular deficits limiting blood flow to the wound area.
- For lower extremity wounds, subject has ankle brachial index less than 0.8, no palpable pulse, or no detectable Doppler signal.
- Individual wounds with necrotic tissue or eschar unless fully debrided.
- Wounds with non-enteric or unexplored fistulas.
- Wounds with tunneling or undermining greater or equal to 2 cm from wound edge.
- Wounds with inadequate hemostasis.
- Wounds exposing vessels, anastomotic sites, organs, or nerves that cannot be protected.
- Wounds deeper than 2 cm (small), 4 cm (medium), or 6 cm (large) dressing size.
- Wounds treated within 30 days before study with negative pressure therapy, growth factors, or bioengineered tissue products.
- Wounds closed with tissue adhesive.
- Wounds deemed unsuitable for the study by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
3
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
Research Team
E
Eric Synatschk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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