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

Completed

Conditions studied: Acute Wounds, Chronic Wounds

In brief

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.

Key facts

Study ID

NCT04342767

Run by

SerenaGroup, Inc.

People needed

28

Starts

2020-05-19

Expected to finish

2020-06-16

Last updated by the study team

2021-03-18

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
• A signed and dated informed consent form.
• Subject is willing and able to comply with instructions and scheduled visits.

You may not qualify if…

• The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
• The subject's wound has not been present for at least 4 weeks.

Where it is running

• Serena Group Research Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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