A Multicenter Retrospective Case Review of Outcomes and Complications of S53P4 Bioactive Glass.

OBJECTIVE

The objective of this multicenter retrospective case review was to assess the natural clinical course, efficacy, and safety of mastoid obliteration with S53P4 Bioactive Glass (bioactive glass).

METHODS

Retrospective case note review in a regional Tertiary Referral Centre and District General Hospital. Patients undergoing mastoid cavity obliteration as part of primary or secondary procedure with bioactive glass between 2012 and 2018. Outcome measures were assessed from a prospectively collated database and case note review. Primary outcomes were the common morbidities of a mastoid cavity; dry or discharging ear (Merchant's scale), vertigo in cold air, and a watertight middle ear. Patients were also assessed for audiological outcomes and recidivism.

RESULTS

Ninety patients were included. During the follow-up period, (mean, 22 months; range, 6-59 months) cholesteatoma recidivism was observed in 2% of ears (2 patients). An acceptably dry (Merchant Grade 0-1) ear was achieved in 91% of all ears (95% primary cases, 80% secondary cases). Delayed healing of the graft in the external ear canal retaining the S53P4BAG Bioactive Glass (BonAlive Ò (BonAlive Ò Biomaterials Ltd., Turku, Finland)) within the mastoid occurred in 13% (12 ears). However, in all cases, conservative management resulted in complete healing.

CONCLUSIONS

Bioactive glass provides a safe and effective means of mastoid obliteration. Complications including overlay graft failure and slow epithelialization, resulting in prolonged postoperative discharge (up to 2 months) and dehiscence into the external ear canal, do not preclude full recovery and may be successfully managed conservatively.