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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


NCT number NCT06116513
Study type Observational
Source Diakonessenhuis, Utrecht
Contact Leij-Halfwerk, Msc, Ir
Phone 088-250 6172
Email Wetenschapsbureau@diakhuis.nl
Status Recruiting
Phase
Start date January 1, 2021
Completion date January 1, 2024