WOUNDS INJURIES
Conditions
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.
Interventions
DEVICEWound 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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADE/SADE | Up to 14 days | Subject incidence of Adverse Device Events (ADEs) and Serious ADEs (SADEs) during the use of the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Wound Area (%) | Up to 14 days | Percent change in total wound area (%) from baseline to end-of-study. |
| Non-viable Tissue (%) | Up to 14 days | Change in the percentage of non-viable tissue from baseline to end-of-study. |
| Total Wound Volume (%) | Up to 14 days | Change in the percentage of total wound volume (%) from baseline to end-of-study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Debridement | Up to 14 days | Subject incidence of bedside debridement. * Subject incidence of operating room debridement. * Number of avoided debridement procedures in the operating room based on physician assessment. |
Countries
United States
Outcome results
None listed