Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

Recruiting

• Conditions: Mastoid Cavity
• Interventions: Device: S53P4 bioactive glass granules

• Registration Number: NCT06116513
• Lead Sponsor: Diakonessenhuis, Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2023-09-18
• Status Verified: 2023-10
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-03
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Old canal wall down cavity
• Operated between 2011 and 2022

Exclusion Criteria

• Middle ear cholesteatoma
• Previous obliteration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with old troublesome radical cavities	S53P4 bioactive glass granules	These patients would have old Canal Wall Down cavities that were troublesome

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands