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

WOUNDS INJURIES Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05748392
• Other study ID #: 05-015054
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries
• WOUNDS INJURIES

Intervention

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.

Locations

Country	Name	City	State
United States	3M	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	ADE/SADE	Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device.	Up to 14 days
Secondary	Total Wound Area (%)	Percent change in total wound area (%) from baseline to end-of-study.	Up to 14 days
Secondary	Non-viable Tissue (%)	Change in the percentage of non-viable tissue from baseline to end-of-study.	Up to 14 days
Secondary	Total Wound Volume (%)	Change in the percentage of total wound volume (%) from baseline to end-of-study.	Up to 14 days