Status:
COMPLETED
A Case Series Study of Negative Pressure Platform Wound Device
Lead Sponsor:
The Metis Foundation
Conditions:
Incisions, Surgical
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
A case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. Patients will be screened for inclusion criteria and asked to consent to p...
Eligibility Criteria
Inclusion
- Patients 18-85 years of age.
- Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04080011
Start Date
August 30 2019
End Date
December 11 2019
Last Update
February 10 2021
Active Locations (1)
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1
Northeast Baptist
San Antonio, Texas, United States, 78217