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| Name | Class |
|---|---|
| Joseph M. Still Research Foundation, Inc. | OTHER |
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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.
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):
**Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invia Motion Endure NPWT system | Other | Use of Negative Pressure Wound Thearpy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invia Motion Endure NPWT system | Device | lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine performance satisfaction of dressing components on periwound | 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) | Up to 4 week study duration |
Inclusion Criteria:
Exclusion Criteria:
Patient not willing to comply with follow up (f/u) clinic visits
Subjects with
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
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| Name | Affiliation | Role |
|---|---|---|
| Claus Brandigi, MD | Joseph M. Still Research Foundation, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital | Augusta | Georgia | 30909 | United States | ||
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| D000072836 | Surgical Wound |
| D004487 | Edema |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 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 |
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 |
| JMS Burn Centers, Inc. at Wellstar Cobb Hospital |
| Austell |
| Georgia |
| 30106 |
| United States |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |