Acute Wounds, Chronic Wounds
Conditions
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.
Interventions
DEVICEEZ 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.
Sponsors
MDM Wound Ventures, LLC
SerenaGroup, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Bioburden | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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 | During debridement | Adverse events associated with mechanical debridement. |
Countries
United States
Outcome results
None listed