A Case Series Study of Negative Pressure Platform Wound Device

Completed · Not applicable

Conditions studied: Incisions, Surgical

In brief

This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.

Key facts

Study ID

NCT04080011

Run by

The Metis Foundation

People needed

10

Starts

2019-08-30

Expected to finish

2019-12-11

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18-85 years of age.
• Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.

You may not qualify if…

• Active infection as judged by the Investigator
• Inability to give informed consent
• Active malignant disease or subject is less than one year disease-free
• Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
• Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing
• On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
• Pregnant at enrollment

Where it is running

• Northeast Baptist — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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