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Completed

NCT Number: NCT04593693

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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**

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invia Motion Endure NPWT system

Device

lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options

Primary outcomes

  1. Goal of therapy: Change in wound volume

    Time frame: 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

  2. Goal of therapy: Change in size of the tunneling area

    Time frame: 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

  3. Goal of therapy: Change in size of undermining

    Time frame: 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

  4. Goal of therapy: Change in amount of slough

    Time frame: 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

  5. Goal of therapy: Change in granulation tissue

    Time frame: 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

  6. Goal of therapy: Change in edema/periwound swelling

    Time frame: 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

  7. 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

    Time frame: 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

Secondary outcomes

  1. Evaluate the ease of use from clinicians

    Time frame: 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)

  2. Evaluate overall satisfaction from clinicians

    Time frame: 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)

Other outcomes

  1. Determine performance satisfaction of dressing components on periwound

    Time frame: Up to 4 week study duration

    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)

Sponsors and collaborators

Lead sponsor

Medela AG

Industry

Collaborators

  • Joseph M. Still Research Foundation, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2020
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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