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

NCT ID: NCT06160505

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Suppurative Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients that underwent mastoidectomy alone

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

No interventions assigned to this group

Patients that underwent mastoidectomy + mastoid obliteration

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

S53P4 Bioactive glass

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diakonessenhuis, Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J.J. Quak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonessenhuis, Utrecht

Locations

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Diakonessenhuis

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Leij-Halfwerk, Msc, Ir

Role: CONTACT

Phone: 0882506172

Email: [email protected]

Facility Contacts

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Leij-Halfwerk, Msc, Ir

Role: primary

Other Identifiers

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16-004-2

Identifier Type: -

Identifier Source: org_study_id