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NCT Number: NCT04342767

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

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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Key information

Conditions

Acute Wounds Chronic Wounds

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EZ Debride®

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SerenaGroup, Inc.

Network

Collaborators

  • MDM Wound Ventures, LLC

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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