Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with old troublesome radical cavities These patients would have old Canal Wall Down cavities that were troublesome |
Device: S53P4 bioactive glass granules
During revision surgery, all infectious material would be removed and subsequently the posterior wall of the external ear canal would be reconstructed and the mastoid would be obliterated using S53P4 bioactive glass.
|
Outcome Measures
Primary Outcome Measures
- Number or participants with a dry ear pre- and postoperatively [At 1, 3 and 5-year postoperatively.]
Postoperative otorrhea as indicated by the Merchant grading system. Grade 0-1 was defined as control of infection and grade 2-3 was defined as failure.
Secondary Outcome Measures
- Pre- and postoperative air conduction [pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively]
Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air conduction in decibel.
- Pre- and postoperative air-bone gap [pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively]
Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air-bone gap in decibel.
- The number of patients with postoperative surgical complications [First year following surgery]
Complications that occured within the first year following surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Old canal wall down cavity
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Operated between 2011 and 2022
Exclusion Criteria:
-
Middle ear cholesteatoma
-
Previous obliteration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diakonessenhuis | Utrecht | Netherlands | 3582KE |
Sponsors and Collaborators
- Diakonessenhuis, Utrecht
Investigators
- Principal Investigator: J.J. Quak, MD, PhD, Diakonessenhuis, Utrecht
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-004-1