3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Wound and per-wound assessments While using Device
3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.
|
Outcome Measures
Primary Outcome Measures
- ADE/SADE [Up to 14 days]
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.
Secondary Outcome Measures
- Total Wound Area (%) [Up to 14 days]
Percent change in total wound area (%) from baseline to end-of-study.
- Non-viable Tissue (%) [Up to 14 days]
Change in the percentage of non-viable tissue from baseline to end-of-study.
- Total Wound Volume (%) [Up to 14 days]
Change in the percentage of total wound volume (%) from baseline to end-of-study.
Other Outcome Measures
- Debridement [Up to 14 days]
Subject incidence of bedside debridement. Subject incidence of operating room debridement. Number of avoided debridement procedures in the operating room based on physician assessment.
Eligibility Criteria
Criteria
Inclusion Criteria
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Subject is at least 22 years old at time of consent.
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Subject OR Legal Authorized Representative is able to provide informed consent.
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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.
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Subject has been diagnosed with a malignancy in the wound.
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Subject has untreated osteomyelitis.
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Subject has an untreated systemic infection.
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Subject has active cellulitis in the peri-wound area.
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Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
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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.
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Subject has had radiation directly to the wound area.
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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.
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Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.
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Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.
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Subject has non-enteric or unexplored fistula.
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Subject has a wound with any unexplored tunneling present.
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Subject has inadequate hemostasis at the wound site, as determined by the investigator.
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Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 3M | Saint Paul | Minnesota | United States | 55144 |
Sponsors and Collaborators
- 3M
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-015054