Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mastoid Cavity
• Intervention / Treatment: Device: S53P4 bioactive glass granules

• Study Type: Observational
• Enrollment (Estimated): 97

Contacts and Locations

• Study Contact: Name: Leij-Halfwerk, Msc, Ir; Phone Number: 088-250 6172; Email: Wetenschapsbureau@diakhuis.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3582KE
    • Recruiting
    • Diakonessenhuis
    • Contact: Phone Number: 088 250 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Middle ear cholesteatoma
• Previous obliteration

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with old troublesome radical cavities; These patients would have old Canal Wall Down cavities that were troublesome	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre- and postoperative air conduction	Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air conduction in decibel.	pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
Pre- and postoperative air-bone gap	Audiological outcomes pre-operatively, compared to early postoperatively (<6months) and late postoperatively (>6months). Evaluated in the audiometry is the air-bone gap in decibel.	pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
The number of patients with postoperative surgical complications	Complications that occured within the first year following surgery	First year following surgery

Collaborators and Investigators

• Sponsor: Diakonessenhuis, Utrecht
• Investigators: Principal Investigator: J.J. Quak, MD, PhD, Diakonessenhuis, Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 16-004-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No