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

NCT ID: NCT05748392

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Wound and per-wound assessments While using Device

Intervention Type: DEVICE

3D imaging and wound and per-wound skin characteristics will be conducted initially, at dressing changes and at end of treatment/study.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

3M

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

05-015054

Identifier Type: -

Identifier Source: org_study_id