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

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

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 Overview

• Status: Withdrawn
• Conditions: WOUNDS INJURIES
• Intervention / Treatment: Device: Wound and per-wound assessments While using Device

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55144
      • 3M

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 05-015054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No