Clinical trial NCT05748392: 3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study
Official title: A Post-market, Multicenter, Prospective, Single-arm Study Evaluating Safety and Performance of the Veraflo™ Cleanse Choice Complete™ Dressing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: WOUNDS INJURIES
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2023-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: ADE/SADE
timeFrame: Up to 14 days
Secondary outcomes:
measure: Total Wound Area (%)
timeFrame: Up to 14 days
measure: Non-viable Tissue (%)
timeFrame: Up to 14 days
measure: Total Wound Volume (%)
timeFrame: Up to 14 days
Other outcomes:
measure: Debridement
timeFrame: Up to 14 days
Locations:
city: Saint Paul
country: United States
facility: 3M
state: Minnesota
Study officials:
References: