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

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.

Study Overview

• Status: Completed
• Conditions: Edema; Surgical Wound; Diabetic Foot Ulcer; Pressure Ulcer; Pressure Injury; Acute Wound; Traumatic Wound; Dehiscence
• Intervention / Treatment: Device: Invia Motion Endure NPWT system

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital
    • Austell, Georgia, United States, 30106
      • JMS Burn Centers, Inc. at Wellstar Cobb Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Invia Motion Endure NPWT system; Use of Negative Pressure Wound Thearpy	Device: Invia Motion Endure NPWT system; lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medela AG
• Collaborators: Joseph M. Still Research Foundation, Inc.
• Investigators: Principal Investigator: Claus Brandigi, MD, Joseph M. Still Research Foundation, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Negative Pressure Wound Therapy; Invia Motion
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Surgical Wound; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: GHC1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No