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

Medela AG25 enrolled

Overview

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.

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\*\*

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Invia Motion Endure NPWT systemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

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