NCT06116513

Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 97 (estimated)
• Sponsor: Diakonessenhuis, Utrecht · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Mastoid Cavity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study