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

Diakonessenhuis, Utrecht

Status: Enrolling

Conditions: Chronic Suppurative Otitis Media

Treatments: Device: S53P4 Bioactive glass

Study type: Observational

Funder types: Other

Identifiers

NCT06160505

16-004-2

Details and patient eligibility

About

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 oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients suffering from middle ear cholesteatoma

Trial design

250 participants in 2 patient groups

Patients that underwent mastoidectomy alone

Description:

This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM without mastoid obliteration

Patients that underwent mastoidectomy + mastoid obliteration

Description:

This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM followed by obliteration of the mastoid cavity using S53P4 bioactive glass

Treatment:

Device: S53P4 Bioactive glass