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

Launched by SOLVENTUM US LLC · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a special dressing called the 3M™ V.A.C. Peel and Place, which is used with a therapy designed to help heal wounds. The study is currently recruiting participants who are at least 22 years old and have specific types of wounds, such as surgical wounds, burns, or ulcers, that can benefit from this treatment. It’s important that participants can attend all study visits and provide informed consent about their involvement in the trial.

Eligible participants will be those without certain health issues, like untreated infections or serious conditions that could affect their ability to follow the study's procedures. If you join the trial, you can expect regular visits to monitor your wound and the effectiveness of the dressing. This study aims to gather important information to help improve wound care for everyone.

Gender

ALL

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: 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.
• 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.