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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593693
• Other study ID #: GHC1901
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: September 2021
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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**

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Wound
• Crush Injuries
• Dehiscence
• Diabetic Foot
• Diabetic Foot Ulcer
• Edema
• Foot Ulcer
• Pressure Injury
• Pressure Ulcer
• Surgical Wound
• Traumatic Wound
• Ulcer
• Wounds and Injuries

Intervention

Device:
• Invia Motion Endure NPWT system
lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options

Locations

Country	Name	City	State
United States	Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital	Augusta	Georgia
United States	JMS Burn Centers, Inc. at Wellstar Cobb Hospital	Austell	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Medela AG	Joseph M. Still Research Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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