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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04342767
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : March 18, 2021
MDM Wound Ventures, LLC
Information provided by (Responsible Party):
SerenaGroup, Inc.

Brief 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.

Condition or disease Intervention/treatment
Acute Wounds Chronic Wounds Device: EZ Debride®

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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".

  2. Adverse Events [ Time Frame: During debridement ]
    Adverse events associated with mechanical debridement.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute or chronic wounds

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04342767

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United States, Pennsylvania
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Sponsors and Collaborators
SerenaGroup, Inc.
MDM Wound Ventures, LLC
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Principal Investigator: Thomas E Serena, MD,FACS SerenaGroup, Inc.
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Responsible Party: SerenaGroup, Inc. Identifier: NCT04342767    
Other Study ID Numbers: EZ-1
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Wounds and Injuries