Evaluating Clinical Acceptance of a NPWT Wound Care System

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds 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

- 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**

B. Secondary Objectives

- To evaluate the ease of use from clinicians.

- To evaluate overall satisfaction from clinicians. C. Tertiary Objectives

- Adequate management of the exudate ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03670225
Study type	Interventional
Source	Medela AG
Contact
Status	Completed
Phase	N/A
Start date	October 16, 2018
Completion date	January 30, 2020

View Details

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