Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass

Conditions
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Mastoid Cavity

Intervention / Treatment
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* Device: S53P4 bioactive glass granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Old canal wall down cavity Operated between 2011 and 2022 Exclusion Criteria: Middle ear cholesteatoma Previous obliteration
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with old troublesome radical cavities<br>These patients would have old Canal Wall Down cavities that were troublesome | Device: S53P4 bioactive glass granules<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number or participants with a dry ear pre- and 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. | At 1, 3 and 5-year postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and postoperative air conduction | Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air conduction in decibel. | pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively | 
| Pre- and postoperative air-bone gap | Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air-bone gap in decibel. | pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively | 
| The number of patients with postoperative surgical complications | Complications that occured within the first year following surgery | First year following surgery |