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Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

NCT06116513 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2023-11-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Diakonessenhuis, Utrecht

    lead OTHER

Principal Investigators

  • J.J. Quak, MD, PhD · Diakonessenhuis, Utrecht

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-01-01
Completion
2024-01-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116513 on ClinicalTrials.gov