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

NCT05748392 | Withdrawn FDA Device

• 1 other identifier: 05-015054
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

WOUNDS INJURIES

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Total Wound Area (%)

  Up to 14 days

• Non-viable Tissue (%)

  Up to 14 days

• Total Wound Volume (%)

  Up to 14 days

Other Outcomes (1)

• Debridement

  Up to 14 days

Study Arms (1)

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

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.

Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

3M

Saint Paul, Minnesota, 55144, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 28, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)