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

Medela

Status: Completed

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

Treatments: Device: Invia Motion Endure NPWT system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04593693

GHC1901

Details and patient eligibility

About

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.

Full 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**

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Invia Motion Endure NPWT system

Other group

Description:

Use of Negative Pressure Wound Thearpy

Treatment:

Device: Invia Motion Endure NPWT system