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BioMed Research International
Volume 2015 (2015), Article ID 242319, 6 pages
Clinical Study

Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study

1AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d’Oto-Rhino-Laryngologie, Département d’Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France
2Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France
3Inserm UMR-S 1159, “Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l’Audition”, 75018 Paris, France

Received 22 May 2015; Accepted 7 July 2015

Academic Editor: Giuseppe Cama

Copyright © 2015 Daniele Bernardeschi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Objective. To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. Material and Methods. Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC) skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance. Results. All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study. Conclusion. The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications.