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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04593693

Run by

Medela AG

People needed

25

Starts

2020-12-10

Expected to finish

2021-05-18

Last updated by the study team

2021-09-24

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
• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.