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

NCT04593693 | Completed FDA Device

• 1 other identifier: GHC1901
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Foot Ulcer; Pressure Injury; Pressure Ulcer; Surgical Wound; Acute Wound; Traumatic Wound; Dehiscence; Edema

Keywords

Negative Pressure Wound Therapy; Invia Motion

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Evaluate the ease of use from clinicians

  Up to 4 week study duration

• Evaluate overall satisfaction from clinicians

  Up to 4 week study duration

Other Outcomes (1)

• Determine performance satisfaction of dressing components on periwound

  Up to 4 week study duration

Study Arms (1)

Invia Motion Endure NPWT system

OTHER

Use of Negative Pressure Wound Thearpy

Device: Invia Motion Endure NPWT system

Interventions

Invia Motion Endure NPWT system DEVICE

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

Invia Motion Endure NPWT system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medela AG: lead
• Joseph M. Still Research Foundation, Inc.: collaborator

Study Sites (2)

Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital

Augusta, Georgia, 30909, United States

Location

JMS Burn Centers, Inc. at Wellstar Cobb Hospital

Austell, Georgia, 30106, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer; Surgical Wound; Edema

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claus Brandigi, MD

  Joseph M. Still Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 20, 2020
• Study Start: December 10, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)