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

Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342767
• Other study ID #: EZ-1
• Status: Completed
• Start date: May 19, 2020
• Est. completion date: June 16, 2020

Study information

• Verified date: March 2021
• Source: SerenaGroup, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Wounds
• Chronic Wounds
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	Serena Group Research Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SerenaGroup, Inc.	MDM Wound Ventures, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Score	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".	Before, during, and after mechanical debridement within 1 hour
Secondary	Adverse Events	Adverse events associated with mechanical debridement.	During debridement