Evaluating Clinical Acceptance of a NPWT Wound Care System

Medela

Status: Completed

Conditions: Pressure Ulcer; Pressure Injury; Diabetic Foot Ulcer

Treatments: Device: Invia Motion Endure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03670225

HC1801

Details and patient eligibility

About

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 of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds 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
• 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**

B. Secondary Objectives

• To evaluate the ease of use from clinicians.
• To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
• Adequate management of the exudate

Enrollment: 10 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 within 72 hours of admission to burn center.
• Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
• 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 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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10 participants in 1 patient group

Invia Motion Endure

Other group

Treatment:

Device: Invia Motion Endure