The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
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|ClinicalTrials.gov Identifier: NCT04342767|
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : March 18, 2021
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.
|Condition or disease||Intervention/treatment|
|Acute Wounds Chronic Wounds||Device: EZ Debride®|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds|
|Actual Study Start Date :||May 19, 2020|
|Actual Primary Completion Date :||June 16, 2020|
|Actual Study Completion Date :||June 16, 2020|
- Device: EZ Debride®
EZ Debride ® is intended for the mechanical debridement of topical wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, second-degree burns and skin tears), draining wounds and tunnelled /undermined wounds.
- Change in Bacterial Bioburden [ Time Frame: Before and After Mechanical debridement within 1 hour ]The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).
- Pain Score [ Time Frame: Before, during, and after mechanical debridement within 1 hour ]
Pain scores (PEG) before, during and after mechanical debridement. Pain intensity of the reference ulcer is assessed before and after any wound cleansing using the PEG score
PEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity). The PEG scale is a validated pain scoring system. It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity. The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain".
- Adverse Events [ Time Frame: During debridement ]Adverse events associated with mechanical debridement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342767
|United States, Pennsylvania|
|Serena Group Research Institute|
|Pittsburgh, Pennsylvania, United States, 15222|
|Principal Investigator:||Thomas E Serena, MD,FACS||SerenaGroup, Inc.|