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NCT06160388
The Safety of S53P4 Bioactive Glass for Mastoid Obliteration
trial testing S53P4 Bioactive glass in Mastoid Cavity in 1,196 participants. Completed in 1 March 2025.
1 September 2024
Quick facts
| Lead sponsor | Diakonessenhuis, Utrecht |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,196 |
| Start date | 1 January 2023 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- S53P4 Bioactive glass
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 recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority. Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties. An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. The investigators will compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06160388
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Related trials
Other trials of S53P4 Bioactive glass
Trials testing the same drug.
- NCT06160505 — Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media · unknown
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
- 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 NCT06160388 (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: 14 July 2025
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/NCT06160388.
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