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The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds

Chronic Wounds Clinical Trial

Official title:
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds

Clinical Trial 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.

Clinical Trial Description

Acute and chronic wounds burden healthcare systems across the globe. In the United States the cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However, evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the EZ Debride® tool reduces bacterial burden. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04342767
Study type Observational
Source SerenaGroup, Inc.
Contact
Status Completed
Phase
Start date May 19, 2020
Completion date June 16, 2020
View Details
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