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

Solventum US LLC

Status: Withdrawn

Conditions: WOUNDS INJURIES

Treatments: Device: Wound and per-wound assessments While using Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05748392

05-015054

Details and patient eligibility

About

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.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Veraflo™ Cleanse Choice Complete™ Dressing Use with Assessments

Other group

Description:

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.

Treatment:

Device: Wound and per-wound assessments While using Device