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

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ClinicalTrials.gov Identifier: NCT04342767
Recruitment Status : Completed
First Posted : April 13, 2020
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
MDM Wound Ventures, LLC
Information provided by (Responsible Party):
SerenaGroup, Inc.

Tracking Information
First Submitted Date April 7, 2020
First Posted Date April 13, 2020
Last Update Posted Date March 18, 2021
Actual Study Start Date May 19, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2020)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 9, 2020)
  • 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".
  • Adverse Events [ Time Frame: During debridement ]
    Adverse events associated with mechanical debridement.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
Official Title The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
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.

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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with acute or chronic wounds
Condition
  • Acute Wounds
  • Chronic Wounds
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 17, 2021)
28
Original Estimated Enrollment
 (submitted: April 9, 2020)
30
Actual Study Completion Date June 16, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04342767
Other Study ID Numbers EZ-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party SerenaGroup, Inc.
Study Sponsor SerenaGroup, Inc.
Collaborators MDM Wound Ventures, LLC
Investigators
Principal Investigator: Thomas E Serena, MD,FACS SerenaGroup, Inc.
PRS Account SerenaGroup, Inc.
Verification Date March 2021