This single blinded clinical trial which was conducted in Alzahra and Kashani hospitals, begin with 56 chronic otitis media patients with perforated tympanic membranes.
Those patients with at least 15 years old, dry ear, no history of Diabetes Mellitus, autoimmune disease, and smoking, included in the study.
Exclusion criteria were: no compliance for follow up, beginning of active otorrhea, ear trauma, and upper airway infection.
Patients are selected by simple randomized method.
28 patients were allocated in group A and 28 patients in group B by random 2 column tables.
All of the patients assign informed consent. The study was approved by Isfahan university of medical sciences ethics committee, Isfahan, Iran. We assert that no financial conflict of interest exists.
At the beginning, demographic data (age, sex, past medical history), physical examination and otoscopic parameters are registered in a form.
Group A patients have tympanoplasty by tympanic membrane grafting medial to malleus. Group B have graftings in the lateral side of the malleus. Surgery is done under general anesthesia, and the graft tissue is harvested from temporalis fascia in both groups.
All of the patients are referred to Otorhinolaryngology clinic for follow up. 3 months after the surgery both groups are examined and tested by audiometry. Success of surgery is defined as complete repair of tympanic membrane, without lateralization, atelectasis, blunting or retraction pocket. Mean air-bone gap before and after tympanoplasty and success rate of tympanoplasty are analyzed with SPSS version 18 by independent T-test, Ki-square, ANCOVA. P- value > 0.05 considered as significant.