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

NCT ID: NCT04593693

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2021-05-18

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**

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Invia Motion Endure NPWT system

Use of Negative Pressure Wound Thearpy

Group Type: OTHER

Invia Motion Endure NPWT system

Intervention Type: DEVICE

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

Interventions

Invia Motion Endure NPWT system

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph M. Still Research Foundation, Inc.

OTHER

Sponsor Role: collaborator

Medela AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Brandigi, MD

Role: PRINCIPAL_INVESTIGATOR

Joseph M. Still Research Foundation, Inc.

Locations

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, United States

Countries

United States

Other Identifiers

GHC1901

Identifier Type: -

Identifier Source: org_study_id