Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

NCT06116513 | Unknown FDA Device

• 1 other identifier: 16-004-1
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastoid Cavity

Outcome Measures

Primary Outcomes (1)

• Number 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.

  At 1, 3 and 5-year postoperatively.

Secondary Outcomes (3)

• Pre- and postoperative air conduction

  pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively

• Pre- and postoperative air-bone gap

  pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively

• The number of patients with postoperative surgical complications

  First year following surgery

Study Arms (1)

Patients with old troublesome radical cavities

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

Device: S53P4 bioactive glass granules

Interventions

S53P4 bioactive glass granules DEVICE

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.

Patients with old troublesome radical cavities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients operated in our hospital between 2011 and 2022 for troublesome radical cavities that received secondary obliteration

You may qualify if:

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

You may not qualify if:

• Middle ear cholesteatoma
• Previous obliteration

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead

Study Sites (1)

Diakonessenhuis

Utrecht, 3582KE, Netherlands

RECRUITING

Study Officials

• J.J. Quak, MD, PhD

  Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leij-Halfwerk, Msc, Ir

CONTACT

088-250 6172; Wetenschapsbureau@diakhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: November 3, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Locations

NL (1)