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Tests treatment safety and results for Wound
Official title A Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing
ClinicalTrials.gov ID: NCT06625385
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- an open wound: traumatic wound, dehisced surgical wound within 30 days of surgery, burn, venous ulcer, diabetic ulcer, or pressure ulcer Note: Prior...
- a closed or covered wound secured with sutures or staples: closed surgical incision, skin flap closure, or skin graft (recipient site)
You likely can't join if
- Subject is pregnant or lactating prior to application of the initial dressing. \ \ Women who have had surgical sterilization by a medically accepted...
- Subject is participating in another treatment 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- Subject is participating in another treatment 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...
- 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
- no discernable audio Doppler signal. Individual wounds are to be excluded from the study if they meet any of the following criteria
- 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.
- Wound contains a non-enteric or unexplored fistula(s) in the wound bed.
- Wound has tunneling.
- Wound has undermining that is ≥ 2 cm in any direction from the wound edge.
- Wound site has inadequate hemostasis, as determined by the investigator.
- 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.
- 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).
- 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.
- Wound was closed with tissue adhesive.
- Wound has, in the opinion of the Investigator, any characteristic that would make it unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Bethlehem, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; St Louis, Missouri, United States; Bethlehem, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.