Last reviewed · How we verify
NCT06160505
Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media
trial testing S53P4 Bioactive glass in Chronic Suppurative Otitis Media in 250 participants. Status unknown.
1 April 2024
Quick facts
| Lead sponsor | Diakonessenhuis, Utrecht |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 1 October 2023 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- S53P4 Bioactive glass
Conditions studied
- Chronic Suppurative Otitis Media — all drugs for Chronic Suppurative Otitis Media →
Sponsor
Diakonessenhuis, Utrecht
Who can join
Eligibility, any sex, with Chronic Suppurative Otitis Media. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06160505
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of S53P4 Bioactive glass
Trials testing the same drug.
- NCT06160388 — The Safety of S53P4 Bioactive Glass for Mastoid Obliteration · completed
Other Diakonessenhuis, Utrecht trials
Trials by the same sponsor.
- NCT06677216 — Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study · enrolling by invitation
- NCT06386341 — QoL in OSA patiënts Treated With MMA Surgery. · recruiting
- NCT06160388 — The Safety of S53P4 Bioactive Glass for Mastoid Obliteration · completed
- NCT05291260 — RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb · NA · active not recruiting
- NCT05535205 — Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06160505 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Diakonessenhuis, Utrecht
- Last refreshed: 7 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06160505.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing