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NCT04753723 · ClinicalTrials.gov registry record · Phase 4
The Use of a Platform Wound Device for Reducing Infection
A Phase 4 study of Wounds and Injury and Burn Wound, sponsored by The Metis Foundation.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT04753723: Completed Phase 4 study of Wounds and Injury and Burn Wound, sponsored by The Metis Foundation.
NCT04753723 is a Phase 4 study of Wounds and Injury and Burn Wound that has completed, run by The Metis Foundation. The registered enrollment target is 48 participants, below the 1,399-participant average among 6 other Wounds and Injury trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04753723, a Phase 4 study of Wounds and Injury and Burn Wound, has completed, sponsored by The Metis Foundation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound, non-inferior to the current standard of care. This treatment will reduce or rapidly eradicate infection.
Primary Outcome
Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Gentamycin with Platform Wound Device
Study Locations (4)
Texas
- Baptist Medical Center - San Antonio
- North East Baptist Hospital - San Antonio
- Mission Trail Baptist Hospital - San Antonio
- North Central Baptist Hospital - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2022-05-25 |
| Phase | Phase 4 |
What the finished NCT04753723 record still lists
NCT04753723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,399-participant average among 6 other Wounds and Injury trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Wounds and Injury appearing as the primary indexed condition, and to 1 intervention - of which Gentamycin with Platform Wound Device is the first listed.
NCT04753723 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04753723 about?
NCT04753723 is a clinical study titled "The Use of a Platform Wound Device for Reducing Infection". This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% Gentamycin cream, to prevent or treat infection in torso and extremity wounds. The hypothesis is that the PWD will be a safe and effective method to provide topical ant...
What is the current status of trial NCT04753723?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2021-02-08. Estimated completion is 2022-05-25.
What conditions does trial NCT04753723 study?
This clinical trial studies the following conditions: Wounds and Injury, Burn Wound, Infection Wound.
What interventions are being tested in trial NCT04753723?
The interventions under investigation include: Gentamycin with Platform Wound Device (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04753723?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04753723 being conducted?
This trial has 4 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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