Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06160505
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media
Sponsor:
Diakonessenhuis, Utrecht
Organization:
Study Overview
Official Title:
Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: