3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
- Conditions
- WOUNDS INJURIES
- Interventions
- Device: Wound and per-wound assessments While using Device
- Registration Number
- NCT05748392
- Lead Sponsor
- Solventum US LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments Wound and per-wound assessments While using Device 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Total Wound Volume (%) Up to 14 days Change in the percentage of total wound volume (%) from baseline to end-of-study.
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.
Trial Locations
- Locations (1)
3M
🇺🇸Saint Paul, Minnesota, United States