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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-19

Study Completion Date

2020-06-16

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.

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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.

Conditions

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Acute Wounds Chronic Wounds

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No