A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
NP-PWD2
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedAugust 14, 2024
August 1, 2024
8 months
July 1, 2024
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility and usability of device in treatment.
The number and type of issues with the device will be documented to determine feasibility and usability. Events such as complications with application, device changes and early removal and rationale for events during the period the patient has the study device applied and throughout the entire enrollment period.
Seven to nine days post application.
Secondary Outcomes (4)
Wound readiness for closure
Seven to nine days post application.
Incidence of colony forming units.
Seven to nine days post application.
Ease of use of device by healthcare providers
Seven to nine days post application.
Tolerability of the device by patient subjects
Seven to nine days post application.
Study Arms (2)
NP-PWD application
EXPERIMENTALPatients randomized to NP-PWD arm will have the NP-PWD device applied to their wound.
Standard of Care Wound VAC application
ACTIVE COMPARATORPatients randomized to the standard of care arm will have the standard wound vac device applied to their wound.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northeast Baptist
San Antonio, Texas, 78217, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodney Chan, MD
The Metis Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
August 14, 2024
Study Start
August 16, 2023
Primary Completion
April 25, 2024
Study Completion
April 25, 2024
Last Updated
August 14, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share