The Safety of S53P4 Bioactive Glass for Mastoid Obliteration

NCT06160388 | Completed FDA Device

• 1 other identifier: 16-004-3
• Study Type: observational
• Target: 1,196
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority. Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties. An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. The investigators will compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries

Conditions

Mastoid Cavity

Outcome Measures

Primary Outcomes (2)

• The number of patients with postoperative surgical complications in the first year following surgery

  Complications that occured within the first year following surgery We compare the obliteration cohort to the non-obliterative cohort

  First year following surgery

• The number of patients which require revision surgery during follow-up

  Revision surgeries performed during follow-up due to problems with the obliteration

  At 3-, 5- and 8-years postoperatively

Study Arms (2)

Patients that underwent mastoidectomy + mastoid obliteration using bioactive glass

This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy followed by obliteration of the mastoid cavity using S53P4 bioactive glass for any indication

Device: S53P4 Bioactive glass

Patients that underwent mastoidectomy alone

This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy without mastoid obliteration for any indication

Interventions

S53P4 Bioactive glass DEVICE

Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.

Patients that underwent mastoidectomy + mastoid obliteration using bioactive glass

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 that were operated in our hospital using a canal wall up or canal wall down mastoidectomy between 2010 and 2022.

You may qualify if:

• Canal wall up or canal wall down mastoidectomy
• Operated between 2010 and 2022
• All indications are included

You may not qualify if:

• Other surgical techniques, such as subtotal petrosectomy

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead

Study Sites (1)

Diakonessenhuis

Utrecht, Utrecht, 3582KE, Netherlands

Location

Study Officials

• J.J. Quak, MD, PhD

  Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-06

Locations

NL (1)