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

NCT04342767 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2021-03-18

No results posted yet for this study

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.

Conditions

  • Acute Wounds
  • Chronic Wounds

Interventions

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.

Sponsors & Collaborators

  • MDM Wound Ventures, LLC

    collaborator UNKNOWN

  • SerenaGroup, Inc.

    lead NETWORK

Principal Investigators

  • Thomas E Serena, MD,FACS · SerenaGroup, Inc.

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2020-06-16
Completion
2020-06-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342767 on ClinicalTrials.gov