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

NCT04342767 | Completed FDA Device

• 1 other identifier: EZ-1
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Wounds; Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Change in Bacterial Bioburden

  The reduction in bacterial bioburden following mechanical wound debridement as determined by the MolecuLight Procedure (MLiX).

  Before and After Mechanical debridement within 1 hour

Secondary Outcomes (2)

• Pain Score

  Before, during, and after mechanical debridement within 1 hour

• Adverse Events

  During debridement

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic wounds

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• MDM Wound Ventures, LLC: collaborator

Study Sites (1)

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Study Officials

• Thomas E Serena, MD,FACS

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: May 19, 2020
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)