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

Chronic Suppurative Otitis Media Clinical Trial

Official title:

Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160505
• Other study ID #: 16-004-2
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Diakonessenhuis, Utrecht
• Contact: Leij-Halfwerk, Msc, Ir
• Phone: 0882506172
• Email: Wetenschapsbureau[@]diakhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Suppurative Otitis Media
• Infections
• Otitis
• Otitis Media
• Otitis Media, Suppurative

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Diakonessenhuis, Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of cases with perforations of the tympanic membrane during follow-up	The number of cases that will develop a perforation of the tympanic membrane during follow-up; We compare the obliteration cohort to the non-obliteration cohort.	Measured at 1-year postoperatively and 3-years postoperatively
Secondary	The difference in air conduction postoperatively	The differences in air conduction postoperatively, as measured in the first audiometry postoperatively in decibel.; We compare the obliteration cohort to the non-obliteration cohort.	First audiometry postoperatively, which is made at 6 months postoperatively
Secondary	The number of cases which require revision surgery during follow-up	The number of cases which require revision surgery during follow-up, for either recurrent CSOM and other indications; We compare the obliteration cohort to the non-obliteration cohort.	Measured at 3-years and 5-years postoperatively