3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
WOUNDS INJURIES
About this trial
This is an interventional treatment trial for WOUNDS INJURIES
Eligibility Criteria
Inclusion Criteria Subject 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.
Sites / Locations
- 3M
Arms of the Study
Arm 1
Other
Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments
Subject will have Veraflo™ Cleanse Choice Complete™ dressing applied and used per instructions for use. 3D imaging and wound / peri-wound skin characteristics will be taken during the treatment.