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A clinical study of human type IV collagen as tympanic membrane grafting material. Preliminary noncomparative study.

OBJECTIVE
To evaluate tolerance for this middle-ear implant and its effectiveness in eardrum healing under various pathologic conditions.


SETTING
A 12- to 18-month follow-up case series at an institutional referral center offering hospitalized care.


PATIENTS
Twenty-six eligible volunteers suffering from tympanic perforation or tympanic pocket retraction class II and III in Tos' classification.


INTERVENTION
Patients underwent implantation with the type IV collagen film (film called "MTY" from the French membrane tympanique). The surgical procedure was similar to those using the temporal aponeurosis or the tragal perichondrium.


OUTCOME MEASURE
Anatomic criteria was determined by otoscopy, and functional audiometric criteria was determined by air-borne gap measurements and by effects on cochlear function.


RESULTS
Twenty-two of 26 patients were completely healed after 6 months, with no subsequent evolution. Nineteen of 26 subjects underwent a 1-year postoperative audiometric follow-up examination: 13 (68%) had an air-borne gap less than 10 dB, four (21%) had between 11 and 20 dB, and two (11%) had between 21 and 30 dB. Adverse effects included one patient whose MTY fell into the middle ear, three patients with transient myringitis, and one patient with otitis media with effusion.


CONCLUSIONS
A human type IV collagen film may be a possible alternative to autologous tissue in tympanic membrane reconstruction. This new biomaterial was tested on patients with various diseases common in clinical otology, and demonstrated a good biocompatibility of MTY in the different pathologic conditions of chronic otitis media. A future randomized, controlled trial will randomly allocate patients to receive either MTY collagen film or tissue from the temporal aponeurosis.