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

NCT06160505 | Unknown FDA Device

• 1 other identifier: 16-004-2
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Suppurative Otitis Media

Outcome Measures

Primary Outcomes (1)

• The number of patients with a dry ear at one-year postoperatively

  The number of cases that have a dry ear at the one-year postoperative out-patient visit. A dry ear is defined as Merchant grade 0 or 1 (No otorrhea or less than one period of otorrhea in the last three months, respectively). A wet ear, thus suffering from otorrhea, is defined as merchant grade 2 or 3 (intermittent more than once in last three months or continuous discharge, respectively). We compare the obliteration cohort to the non-obliteration cohort.

  At 1-year postoperatively

Secondary Outcomes (3)

• The number of cases with perforations of the tympanic membrane during follow-up

  Measured at 1-year postoperatively and 3-years postoperatively

• The difference in air conduction postoperatively

  First audiometry postoperatively, which is made at 6 months postoperatively

• The number of cases which require revision surgery during follow-up

  Measured at 3-years and 5-years postoperatively

Study Arms (2)

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

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

Device: S53P4 Bioactive glass

Interventions

S53P4 Bioactive glass 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.

Patients that underwent mastoidectomy + mastoid obliteration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients that underwent canal wall up or canal wall down mastoidectomy between 2010 and 2022 will be evaluated. Only cases that full-fill the in- and exclusion criteria will be selected. Patients will be stratified for whether they received mastoid obliteration or not.

You may qualify if:

• 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

You may not qualify if:

• Patients suffering from middle ear cholesteatoma

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead

Study Sites (1)

Diakonessenhuis

Utrecht, 3582KE, Netherlands

RECRUITING

Study Officials

• J.J. Quak, MD, PhD

  Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leij-Halfwerk, Msc, Ir

CONTACT

0882506172; Wetenschapsbureau@diakhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

NL (1)