Status:
UNKNOWN
Use of Autologous Plasma Rich in Platelets and Extracellular Vesicles in the Surgical Treatment of Chronic Middle Ear Infections
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
University of Ljubljana
Conditions:
Otitis Media Chronic
Tympanic Membrane Perforation
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma as a supplement to the surgical treatment of chronic tympanic ...
Detailed Description
The study is designed to be mono-centric, prospective, double-blind, parallel, uniformly randomised, controlled, with a fixed sample. The purpose of the study is to determine whether autologous plate...
Eligibility Criteria
Inclusion
- tympanic membrane,
- dry middle ear cavity,
- absence of exclusion criteria.
Exclusion
- signs of cholesteatoma,
- anemia,
- thrombocytopenia,
- chronic use of immunomodulatory agents and / or antimicrobials,
- malignancy in the ear area,
- systemic infectious disease,
- autoimmune disease,
- inability and / or refusal of the patient to participate in the research,
- pregnancy and / or breast-feeding.
Key Trial Info
Start Date :
February 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04761562
Start Date
February 14 2021
End Date
September 30 2023
Last Update
February 21 2021
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000