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

Primary Purpose

Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Invia Motion Endure NPWT system
Sponsored by
Medela AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Negative Pressure Wound Therapy, Invia Motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital
  • JMS Burn Centers, Inc. at Wellstar Cobb Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Invia Motion Endure NPWT system

Arm Description

Use of Negative Pressure Wound Thearpy

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
September 17, 2020
Last Updated
September 23, 2021
Sponsor
Medela AG
Collaborators
Joseph M. Still Research Foundation, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04593693
Brief Title
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medela AG
Collaborators
Joseph M. Still Research Foundation, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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**

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound, Acute Wound, Traumatic Wound, Dehiscence, Edema
Keywords
Negative Pressure Wound Therapy, Invia Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Invia Motion Endure NPWT system
Arm Type
Other
Arm Description
Use of Negative Pressure Wound Thearpy
Intervention Type
Device
Intervention Name(s)
Invia Motion Endure NPWT system
Intervention Description
lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
Primary Outcome Measure Information:
Title
Goal of therapy: Change in wound volume
Description
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
Time Frame
Up to 4 week study duration
Title
Goal of therapy: Change in size of the tunneling area
Description
Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Title
Goal of therapy: Change in size of undermining
Description
Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Title
Goal of therapy: Change in amount of slough
Description
Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Title
Goal of therapy: Change in granulation tissue
Description
Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Title
Goal of therapy: Change in edema/periwound swelling
Description
Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Title
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
Description
Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached
Time Frame
Up to 4 week study duration
Secondary Outcome Measure Information:
Title
Evaluate the ease of use from clinicians
Description
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)
Time Frame
Up to 4 week study duration
Title
Evaluate overall satisfaction from clinicians
Description
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)
Time Frame
Up to 4 week study duration
Other Pre-specified Outcome Measures:
Title
Determine performance satisfaction of dressing components on periwound
Description
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)
Time Frame
Up to 4 week study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Brandigi, MD
Organizational Affiliation
Joseph M. Still Research Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
JMS Burn Centers, Inc. at Wellstar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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