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


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.


CONCLUSIONS
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.
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Daniele
D
Bernardeschi
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Yann
Y
Nguyen
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Francesca Yoshie
FY
Russo
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Isabelle
I
Mosnier
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Evelyne
E
Ferrary
AP-HP, Groupe Hospitalier Pitié-Salpêtrière, Service d'Oto-Rhino-Laryngologie, Département d'Otologie, Implants Auditifs et Chirurgie de Base du Crâne, 75013 Paris, France ; Sorbonne Universités, UPMC Univ Paris 06, 75005 Paris, France ; Inserm UMR-S 1159, "Réhabilitation Chirurgicale Mini-Invasive et Robotisée de l'Audition", 75018 Paris, France.
Olivier
O
Sterkers
D000293:Adolescent; D000328:Adult; D000368:Aged; D018786:Bone Substitutes / Q000009:adverse effects*; D004361:Drug Tolerance; D007758:Ear, Inner / Q000187:drug effects*; D005260:Female; D005898:Glass; D006801:Humans; D008297:Male; D008416:Mastoid / Q000601:surgery; D008422:Materials Testing; D008875:Middle Aged; D010031:Otitis / Q000175:diagnosis / Q000601:surgery*; D013506:Otologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D012867:Skin / Q000187:drug effects*; D016896:Treatment Outcome; D014432:Tympanic Membrane; D055815:Young Adult
D018786:Bone Substitutes; C403922:bioactive glass S53P4