Trials / Completed
CompletedNCT04593693
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Medela AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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\*\*
Conditions
- Diabetic Foot Ulcer
- Pressure Injury
- Pressure Ulcer
- Surgical Wound
- Acute Wound
- Traumatic Wound
- Dehiscence
- Edema
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Invia Motion Endure NPWT system | lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options |
Timeline
- Start date
- 2020-12-10
- Primary completion
- 2021-05-18
- Completion
- 2021-05-18
- First posted
- 2020-10-20
- Last updated
- 2021-09-24
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04593693. Inclusion in this directory is not an endorsement.