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NCT04342767 · ClinicalTrials.gov registry record
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
A clinical trial, sponsored by SerenaGroup.
- Completed
- Registry status
- 28
- Enrollment target
NCT04342767: Completed study, sponsored by SerenaGroup.
NCT04342767 is a clinical trial that has completed, run by SerenaGroup. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04342767 has completed, sponsored by SerenaGroup.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ Debride device after which a second MLiX procedure is performed. The investigator will then compare the two images.
Primary Outcome
The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).
Interventions
- DEVICE EZ Debride®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-05-19 |
| Est. Completion | 2020-06-16 |
What the finished NCT04342767 record still lists
NCT04342767 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which EZ Debride® is the first listed.
NCT04342767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04342767 about?
NCT04342767 is a clinical study titled "The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds". This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight i...
What is the current status of trial NCT04342767?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2020-05-19. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT04342767?
The interventions under investigation include: EZ Debride® (DEVICE).
Who is sponsoring clinical trial NCT04342767?
This trial is sponsored by SerenaGroup, which has 10 total clinical trials registered on ClinicalTrials.gov.
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