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

Exclusion Criteria30

• 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.
• Subject is participating in another interventional 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 (wound/peri-wound condition).
• 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.