Actively Recruiting
A Post-market, Prospective, Multi-center, Single-arm Study Evaluating the Safety and Efficacy of the 3M 20V.A.C. Peel and Place Dressing Used with 3M 20V.A.C. AE Therapy
Led by Solventum US LLC · Updated on 2026-02-13
90
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the 3M 20V.A.C. AE Peel and Place dressing when used with 3M 20V.A.C. AE Therapy for treating various wound types. This study collects post-market data to better understand how well this dressing works and how safe it is for patients with open or closed wounds. The study is prospective, conducted at multiple centers, and involves a single group of participants. Participants will receive the 3M 20V.A.C. AE Peel and Place dressing applied along with 3M 20V.A.C. AE Therapy. The study plans to enroll about 90 subjects, each with one study wound, including 60 open wounds and 30 closed or covered wounds. Treatment includes an initial dressing application, with dressing changes as needed but no more than 7 days apart, followed by an end-of-treatment visit between 7 and 14 days after the first application. Participants will be involved for up to 20 days, beginning with a screening period up to 5 days. During the study, researchers will monitor the incidence of adverse device effects and assess wound healing, including the closure of surgical incisions and skin flaps, skin graft success, and overall wound healing rates. Safety and healing outcomes will be evaluated at 14 days, with multiple clinical visits for dressing changes and assessments.
CONDITIONS
Brief 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 V.A.C. Peel and Place dressing with 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, 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 prior to initial dressing application, unless surgically sterilized or post-menopausal.
- Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
- Subject has a malignancy diagnosed in the wound.
- Subject has untreated osteomyelitis or cellulitis in the wound.
- Subject has an untreated systemic infection.
- Subject has active cellulitis in the peri-wound area.
- Subject has known allergy or hypersensitivity to dressing materials like acrylic, silicone adhesives, or polyurethane.
- Subject has any clinically significant condition impairing compliance or assessment.
- Subject had radiation directly to the wound area.
- Subject received hyperbaric oxygen therapy within 30 days before initial dressing.
- Subject has major vascular deficits limiting blood flow to the wound.
- For lower extremity wounds, subject has ankle brachial index < 0.8, no palpable pulse, or no Doppler signal.
- Individual wounds with necrotic tissue or eschar (unless debrided), non-enteric fistulas, tunneling, undermining ≥ 2 cm, inadequate hemostasis, exposed vessels/organs/nerves not protected, excessive depth (over 2, 4, or 6 cm depending on dressing size), recent negative pressure wound therapy, growth factors, bioengineered tissue products, tissue adhesive closure, or unsuitable characteristics per investigator are excluded.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 5 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 days including initial treatment and dressing changes
Participants receive the 3M™ V.A.C.® Peel and Place Dressing used with 3M™ V.A.C.® Therapy applied to their wound. Dressing change visits occur as clinically appropriate but no more than every 7 days from dressing application.
Dressing change visits as clinically appropriate but no more than every 7 days; end-of-treatment visit between Day 7 and Day 14 after initial dressing application
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
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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