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.
Study Type
OBSERVATIONAL
Enrollment
97
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.
Diakonessenhuis
Utrecht, Netherlands
RECRUITINGNumber 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.
Time frame: At 1, 3 and 5-year postoperatively.
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.
Time frame: 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.
Time frame: 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
Time frame: First year following surgery
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