Status:
COMPLETED
A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
Lead Sponsor:
The Metis Foundation
Conditions:
Skin Wound
Soft Tissue Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.
Detailed Description
A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked t...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All subjects enrolled must meet ALL the following criteria:
- Patients 18 years of age or older of either gender
- Have an open skin or soft tissue defect requiring treatment
- Exclusion Criteria
- Subjects who meet any of the following criteria will be excluded from the study:
- Active malignant disease at the study site
- Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
- On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
- Pregnant at enrollment
Exclusion
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06552481
Start Date
August 16 2023
End Date
April 25 2024
Last Update
August 14 2024
Active Locations (1)
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1
Northeast Baptist
San Antonio, Texas, United States, 78217