Status:
COMPLETED
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds
Lead Sponsor:
SerenaGroup, Inc.
Collaborating Sponsors:
MDM Wound Ventures, LLC
Conditions:
Acute Wounds
Chronic Wounds
Eligibility:
All Genders
18-99 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 16 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04342767
Start Date
May 19 2020
End Date
June 16 2020
Last Update
March 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222