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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Wounds, Chronic Wounds

Intervention / Treatment
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* Device: EZ Debride®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bacterial Bioburden | The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX). | Before and After Mechanical debridement within 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 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. | Before, during, and after mechanical debridement within 1 hour | 
| Adverse Events | Adverse events associated with mechanical debridement. | During debridement |