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

Not Applicable

Completed

• Conditions: Traumatic Wound; Diabetic Foot Ulcer; Pressure Ulcer; Surgical Wound; Acute Wound; Edema; Pressure Injury; Dehiscence
• Interventions: Device: Invia Motion Endure NPWT system

• Registration Number: NCT04593693
• Lead Sponsor: Medela AG

Brief 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\*\*

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2020-12-10
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Invia Motion Endure NPWT system	Invia Motion Endure NPWT system	Use of Negative Pressure Wound Thearpy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluate the ease of use from clinicians	Up to 4 week study duration	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)
Evaluate overall satisfaction from clinicians	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)

Trial Locations

Locations (2)

JMS Burn Centers, Inc. at Wellstar Cobb Hospital; 🇺🇸 Austell, Georgia, United States

Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital; 🇺🇸 Augusta, Georgia, United States