Evaluating Clinical Acceptance of a NPWT Wound Care System

Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types

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 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

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.