NCT05748392WithdrawnNot Applicable
A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Solventum US LLC
- Locations
- 1
- Primary Endpoint
- ADE/SADE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments
Other
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.
Intervention: Wound and per-wound assessments While using Device (Device)
Outcomes
Primary Outcomes
ADE/SADE
Time Frame: Up to 14 days
Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.
Secondary Outcomes
- Total Wound Volume (%)(Up to 14 days)
- Total Wound Area (%)(Up to 14 days)
- Non-viable Tissue (%)(Up to 14 days)
Investigators
Study Sites (1)
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