Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342767
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 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
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : November 1, 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.


Layout table for eligibility information
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04342767


Contacts
Layout table for location contacts
Contact: Thomas E Serena, MD,FACS 814- 688-4000 serena@serenagroups.com
Contact: Derek Denton 210-414-3213 ddenton@ezdebride.com

Locations
Layout table for location information
United States, Pennsylvania
Serena Group Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15222
Contact: Thomas E Serena, MD    814-688-4000    serena@serenagroups.com   
Contact: Laura Serena, LPN    412-212-0123    lserena@serenagroups.com   
Principal Investigator: Thomas E Serena, MD         
Sponsors and Collaborators
SerenaGroup, Inc.
MDM Wound Ventures, LLC
Investigators
Layout table for investigator information
Principal Investigator: Thomas E Serena, MD,FACS SerenaGroup, Inc.
Layout table for additonal information
Responsible Party: SerenaGroup, Inc.
ClinicalTrials.gov Identifier: NCT04342767    
Other Study ID Numbers: EZ-1
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Wounds and Injuries