Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

Diakonessenhuis, Utrecht

Status: Enrolling

Conditions: Mastoid Cavity

Treatments: Device: S53P4 bioactive glass granules

Study type: Observational

Funder types: Other

Identifiers

NCT06116513

16-004-1

Details and patient eligibility

About

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.

Enrollment: 97 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Middle ear cholesteatoma
• Previous obliteration

Trial design

97 participants in 1 patient group

Patients with old troublesome radical cavities

Description:

These patients would have old Canal Wall Down cavities that were troublesome

Treatment:

Device: S53P4 bioactive glass granules