Clinical trial NCT06160388: The Safety of S53P4 Bioactive Glass for Mastoid Obliteration
Official title: The Short- and Long-Term Safety of S53P4 Bioactive Glass for Mastoid Obliteration: a Retrospective Comparative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastoid Cavity
Lead sponsor: Diakonessenhuis, Utrecht
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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. We compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other surgical techniques, such as subtotal petrosectomy

Primary outcomes:
measure: The number of patients with postoperative surgical complications in the first year following surgery
timeFrame: First year following surgery
measure: The number of patients which require revision surgery during follow-up
timeFrame: At 3-, 5- and 8-years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: J.J. Quak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: