NCT06160505View on ClinicalTrials.gov

Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media

RecruitingOBSERVATIONAL

Enrollment

250

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

June 1, 2024

Conditions

Chronic Suppurative Otitis Media

Interventions

DEVICE

S53P4 Bioactive glass

Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.

Trial Locations (1)

3582KE

RECRUITING

Diakonessenhuis, Utrecht

All Listed Sponsors

lead

Diakonessenhuis, Utrecht

OTHER