Tympanic membrane healing process and biocompatibility of an innovative absorbable ventilation tube.
OBJECTIVE
To investigate tympanic membrane healing process and biocompatibility of pressure-equalizing (PE) tubes, made of a novel biodegradable, absorbable material, in an animal model.


BACKGROUND
Myringotomy and pressure-equalizing tube insertion is a frequent otologic procedure in children. However, results may vary because of the unpredictable extrusion rate of tubes. Furthermore, tubes that are no longer required need a surgical procedure to be removed. The ideal pressure-equalizing tube should remain in place for the time selected by the otologist, with no need for subsequent removal. This objective could be met with pressure-equalizing tubes made from a self-disintegrating material.


METHODS
Pressure-equalizing tubes, made of poly-bis(ethylalanate)phosphazene, were inserted in 55 ears of 28 Hartley guinea pigs, with survival times of 10, 30, and 60 days after tube insertion. In vivo reactions between the poly-bis(ethylalanate)phosphazene pressure-equalizing tubes and the tympanic membrane were studied. Tympanic membranes, middle ears, and tubes were examined by scanning electron microscopy.


RESULTS
There was neither infection nor inflammatory reaction to the tube in any animal. The healing process of tympanic membranes revealed neither residual perforation nor inward spread of skin epithelium into the middle ear cavity. At 30 days, 53% of the tubes had disintegrated. At 60 days, tubes were functioning in 25% of ears.


CONCLUSIONS
These new poly-bis(ethylalanate)phosphazene pressure-equalizing tubes are promising. The healing process of tympanic membranes is excellent, with no complications. The tube disintegration rate can be controlled by varying the formulation of the polymer, obtaining tubes with predictable resorption rates, to adapt treatment to the needs of each single patient.
D' Eredità
Riccardo
R
Division of Pediatric Otolaryngology, Department of Otorhinolaryngology-Head and Neck Surgery, Vicenza Civil Hospital, Vicenca, Italy. riccardo.deredita@ulssvicenza
Marsh
Roger R
RR
D020341:Absorbable Implants; D000818:Animals; D001672:Biocompatible Materials; D006168:Guinea Pigs; D008876:Middle Ear Ventilation / Q000295:instrumentation*; D009943:Organophosphorus Compounds; D010034:Otitis Media with Effusion / Q000601:surgery; D011897:Random Allocation; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000601:surgery*; D014945:Wound Healing
D001672:Biocompatible Materials; D009943:Organophosphorus Compounds