Evaluating Clinical Acceptance of a NPWT Wound Care System

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer

In brief

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.

Key facts

Study ID

NCT03670225

Run by

Medela AG

People needed

10

Starts

2018-10-16

Expected to finish

2020-01-30

Last updated by the study team

2020-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Joseph M. Still Research Foundation — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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