3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study | NCT05748392

NCT05748392

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
3M	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Wound and per-wound assessments While using Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wound and per-wound assessments While using Device	Device	3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.

Outcomes Module

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 Outcomes

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.

Other Outcomes

Measure	Description	Time Frame
Debridement	Subject incidence of bedside debridement. Subject incidence of operating room debridement. Number of avoided debridement procedures in the operating room based on physician assessment.	Up to 14 days

Eligibility Module

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.