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

Withdrawn before enrolling · Not applicable

Conditions studied: WOUNDS INJURIES

In brief

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.

Key facts

Study ID

NCT05748392

Run by

Solventum US LLC

People needed

0

Starts

2023-06-01

Expected to finish

2023-06-01

Last updated by the study team

2024-10-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.

Where it is running

• 3M — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.