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December 1994

A Clinical Study of Human Type IV Collagen as Tympanic Membrane Grafting Material: Preliminary Noncomparative Study

Author Affiliations

From the Department of Otorhinolaryngology (Drs Truy, Disant, and Morgan) and the Départment de Physiologie sensorielle "Audition et Voix" (Drs Truy, Froehlich, and Morgan), Edouard Herriot Hospital, and IMEDEX (Dr Tiollier), Lyon, France.

Arch Otolaryngol Head Neck Surg. 1994;120(12):1329-1332. doi:10.1001/archotol.1994.01880360027005

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-bone 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-bone 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.(Arch Otolaryngol Head Neck Surg. 1994;120:1329-1332)

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