Status:
COMPLETED
Efficacy of Platelet- and Extracellular Vesicle-rich Plasma in Chronic Postsurgical Temporal Bone Inflammations
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
University of Ljubljana
University of Ljubljana, Faculty of Medicine
Conditions:
Otitis Media Chronic
Temporal Bone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical study evaluates the efficacy of the autologous blood-derived product called platelet- and extracellular vesicle-rich plasma (PVRP) for the treatment of chronically inflamed post-surgical...
Detailed Description
The hypothesis of this study is that platelet- and extracellular vesicle-rich plasma (PVRP) may be efficient in the treatment of chronically inflamed post-surgical temporal bone cavities. Platelet-ri...
Eligibility Criteria
Inclusion
- chronic otitis media, defined as a presence of at least 1 of the following: visible ear discharge, indirect signs of ear discharge (e.g. on a pillow, clothes), ear itching, the sensation of ear fullness, clinical signs of acute exacerbation of chronic otitis media during an otomicroscopic examination.
- non-cholesteatomatous chronic otitis media despite prior standard conservative treatment
- non-cholesteatomatous chronic otitis media despite prior surgical treatment
Exclusion
- the presence or suspicion of cholesteatoma
- infection of venepuncture site
- pregnancy
- breastfeeding
- long-term treatment with antimicrobial drugs
- long-term treatment with immunosuppressant drugs
- the presence of systemic infectious disease
- the presence of an autoimmune disease
- the presence of cancer
- receiving other types of experimental treatment for chronic otitis media
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04281901
Start Date
March 20 2019
End Date
October 14 2020
Last Update
August 3 2021
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000