Status:
UNKNOWN
Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media
Lead Sponsor:
Diakonessenhuis, Utrecht
Conditions:
Chronic Suppurative Otitis Media
Eligibility:
All Genders
Brief Summary
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and ora...
Eligibility Criteria
Inclusion
- Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively
- At least one year of follow-up, in order to asses the primary outcome
- Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement
- Canal wall up or canal wall down mastoidectomy
- Operated between 2010 and 2022
Exclusion
- Patients suffering from middle ear cholesteatoma
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06160505
Start Date
October 1 2023
End Date
June 1 2024
Last Update
December 7 2023
Active Locations (1)
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1
Diakonessenhuis
Utrecht, Netherlands, 3582KE