NCT03670225

Evaluating Clinical Acceptance of a NPWT Wound Care System

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: 10 (actual)
• Sponsor: Medela AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Diabetic Foot Ulcer
• Pressure Injury
• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Invia Motion Endure	NPWT Invia Motion Endure

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2018-09-13
• Last updated: 2020-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study