Acute Wound, Dehiscence, Diabetic Foot Ulcer, Edema, Pressure Injury, Pressure Ulcer, Surgical Wound, Traumatic Wound
Conditions
Keywords
Negative Pressure Wound Therapy, Invia Motion
Brief summary
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
Detailed description
The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration. \* Goal of therapy will be defined by the physician according to initial assessment: Endpoints (dependent on goal of therapy): * Decrease in wound volume * Decrease in size of the tunneling area * Decrease in size of undermining * Decrease in amount of slough * Increase in granulation tissue * Decrease in edema/periwound swelling * The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft. \*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*
Interventions
DEVICEInvia Motion Endure NPWT system
lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
Sponsors
Joseph M. Still Research Foundation, Inc.
Medela AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects ≥18 years of age. * Signed, informed consent by patient or LAR * Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema * Patient is comfortable (e.g. not in pain) * Patient is willing and able to adhere to treatment protocol.
Exclusion criteria
* Patient not willing to comply with follow up (f/u) clinic visits * Subjects with * Necrotic tissue with eschar present * Untreated osteomyelitis * Non-enteric and unexplored fistulas * Malignancy in wound * Exposed vasculature * Exposed nerves * Exposed anastomotic site of blood vessels or bypasses * Exposed organs * Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. * Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal of therapy: The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft | Up to 4 week study duration | Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached |
| Goal of therapy: Change in amount of slough | Up to 4 week study duration | Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached |
| Goal of therapy: Change in granulation tissue | Up to 4 week study duration | Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached |
| Goal of therapy: Change in edema/periwound swelling | Up to 4 week study duration | Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached |
| Goal of therapy: Change in wound volume | Up to 4 week study duration | Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached |
| Goal of therapy: Change in size of the tunneling area | Up to 4 week study duration | Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached |
| Goal of therapy: Change in size of undermining | Up to 4 week study duration | Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the ease of use from clinicians | Up to 4 week study duration | A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine ease of use on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied) |
| Evaluate overall satisfaction from clinicians | Up to 4 week study duration | A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine overall satisfaction with the device on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine performance satisfaction of dressing components on periwound | Up to 4 week study duration | A weekly staff satisfaction survey on the ability to maintain dressing seal will be obtained from the wound clinic staff members to determine performance satisfaction of dressing components on periwound on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied) |
Countries
United States
Outcome results
None listed