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

Study Overview
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Brief Summary
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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.

Official Title
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A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing

Conditions
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WOUNDS INJURIES

Intervention / Treatment
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* Device: Wound and per-wound assessments While using Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments<br>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. | Device: Wound and per-wound assessments While using Device<br>* 3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADE/SADE | Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device. | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Wound Area (%) | Percent change in total wound area (%) from baseline to end-of-study. | Up to 14 days | 
| Non-viable Tissue (%) | Change in the percentage of non-viable tissue from baseline to end-of-study. | Up to 14 days | 
| Total Wound Volume (%) | Change in the percentage of total wound volume (%) from baseline to end-of-study. | Up to 14 days |