Comparing the effectiveness of tympanoplasty with temporalis fascia and fibrin glue with the routine method of tympanoplasty with temporalis fascia and Gelfoam

Comparing the effectiveness of tympanoplasty with temporalis fascia and fibrin glue with the routine method of tympanoplasty with temporalis fascia and Gelfoam

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 90 patients. Block randomization method in 15 blocks of 6 and randomization.com online software is used to randomize patients.

This study is conducted in Amirkabir hospital in Arak city on 90 candidates for tympanoplasty with temporalis fascia. Patients will be divided into intervention and control groups by block randomization method. 45 patients in the intervention group underwent tympanoplasty surgery with temporalis fascia and fibrin glue and 45 patients in the control group underwent tympanoplasty surgery with temporalis fascia and gelfoam by the same surgeon. This study is double-blind and the patient, clinical caregiver, and data analyst will be blinded to the study groups.

Inclusion criteria: partial rupture of the tympanic membrane, age 18 to 60 years. Exclusion criteria: presence of cholesteatoma or other pathology

In the intervention group, patients will undergo tympanoplasty surgery through the back of the ear using fibrin glue. In the control group, patients will undergo tympanoplasty surgery by the same surgeon through the back of the ear using Gelfoam.

The average tone of the pure voice, Graft take rate.

Randomization in this study will be done using randomization.com online software and block method. In this way, random sequences are produced in 15 blocks of 6 and patients will be divided into A or B groups based on the order of the generated sequences. Concealment is done by using non-transparent sealed envelopes in such a way that a number of envelopes with aluminum cover are prepared and each of the random sequences created is recorded on a card. The cards are placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. At the start of the study, according to the order of entry of the participants, one of the letter envelopes will be opened and the assigned group of that participant will be revealed.

Blinding in this study will be double-blind. In this way, patients will not know about the type of surgery performed. Also, the project administrator, who is responsible for evaluating patients and recording information, and the statistical consultant of the project, who is responsible for data analysis, will recognize patients only through groups A and B. Only the project surgeon who is responsible for performing tympanoplasty surgery for the patients will know about the study groups.