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NCT06116513
Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass
trial testing S53P4 bioactive glass granules in Mastoid Cavity in 97 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Diakonessenhuis, Utrecht |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 97 |
| Start date | 1 January 2021 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- S53P4 bioactive glass granules
Conditions studied
- Mastoid Cavity — all drugs for Mastoid Cavity →
Sponsor
Diakonessenhuis, Utrecht
Who can join
Eligibility, any sex, with Mastoid Cavity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. Secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the EAC can help alleviate these symptoms. Our goal is to study the efficacy of secondary obliteration using S53P4 bioactive glass as obliteration material. This bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. The main outcome will be postoperative otorrhea as indicated by the Merchant grading scale.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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
- NCT06160505 — Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media · unknown
- 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
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 NCT06116513 (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: 3 November 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/NCT06116513.
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