A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System

Study Overview
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Brief Summary
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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
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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**

Official Title
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A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types

Conditions
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Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound, Acute Wound, Traumatic Wound, Dehiscence, Edema

Intervention / Treatment
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* Device: Invia Motion Endure NPWT system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Invia Motion Endure NPWT system<br>Use of Negative Pressure Wound Thearpy | Device: Invia Motion Endure NPWT system<br>* lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal of therapy: Change in wound volume | 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 | Up to 4 week study duration | 
| Goal of therapy: Change in size of the tunneling area | Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached | Up to 4 week study duration | 
| Goal of therapy: Change in size of undermining | Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached | Up to 4 week study duration | 
| Goal of therapy: Change in amount of slough | Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached | Up to 4 week study duration | 
| Goal of therapy: Change in granulation tissue | Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached | Up to 4 week study duration | 
| Goal of therapy: Change in edema/periwound swelling | Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached | Up to 4 week study duration | 
| 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 | Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached | Up to 4 week study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ease of use from clinicians | 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) | Up to 4 week study duration | 
| Evaluate overall satisfaction from clinicians | 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) | Up to 4 week study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative Pressure Wound Therapy, Invia Motion