3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study

The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.

Inclusion CriteriaSubject is at least 22 years old at time of consent.Subject OR Legal Authorized Representative is able to provide informed consent.Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.Exclusion Criteria:Subject is pregnant prior to application of the initial dressing**Women who have had surgical sterilization by a medically accepted method (i.e. 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 has been diagnosed with a malignancy in the wound.Subject has untreated osteomyelitis.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.Subject has had radiation directly to the wound area.Subject has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.Subject has non-enteric or unexplored fistula.Subject has a wound with any unexplored tunneling present.Subject has inadequate hemostasis at the wound site, as determined by the investigator.Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.