The effect of pre-operation Povidone-iodine irrigation on sensory neural hearing loss in Tympanoplasty

Comparison of the effect of pre-operation irrigation with 5% and 10% Povidone-iodine on sensory neural hearing loss and tympanic membrane repair after Tympanoplasty.

Randomised clinical trial, double-blind, prospective Since there is no similar human study with completely similar results, the sample size in each group will be equal to the minimum number required for parametric tests, with at least 30 individuals in each group.

in Shiraz University of medical science in Khalili Hospital. Number of at least 60 patients requiring tympanoplasty will be randomly divided into two groups with the block randomization method according to the percent of betadine used. Since the examining professor and the patient are unaware of the percent of iodine use, the study is double blind.

Patients' inclusion criteria for this study include: 1) Normal mucosa 2) The ear must be dry for at least one month before surgery and must be free of inflammation and infection. 3) The size of the tympanic membrane rupture should be more than 50%. 4) Normal ossicle status of ear. 5) Age must be older than 18 years old 6) Those who do not have cholesteatoma, granulation tissue, and tympanosclerosis plaque. Exclusion criteria for this study include: 1) If the patient does not meet any of the above criteria will be excluded 2) Age under 18 years old 3) Those who got followed up for less than 6 months 4) Smokers, diabetics, liver and kidney failure

To disinfect the external ear in the first group 5%Betadine and in the second group 10%Betadine will be poured in the ear and will be kept for 5 minutes. Audiometry will be performed one week before surgery and 6 months after surgery That will be analyzed for practice.

Graft Success Rate Sensory Neural Hearing Loss

Number of at least 60 patients requiring tympanoplasty will be randomly divided into two groups with the block randomization method according to the percent of betadine used. Given the block size of 2 there are two ways to assign participants to a block. AB or BA. (A) stands for 5% betadine and (B) stands for 10% betadine. Using Microsoft Excel software we will produce 30 numbers equal to the sample size in each group between 0 to 9. For numbers 0, 2, 4, 6, 8 AB combination and for numbers 1, 3, 5, 7, 9 BA combination will be chosen.

all patients will undergo surgery by Dr Mohammed Faramarzi consultant professor at Dastgheib and Dena hospital and will be examined by a supervisor professor Dr Mahmoud Shishagar in 1, 2, 3 and 6 months after operation in Khalili hospital and Motahari clinic. Although the first surgeon visits the patients himself but intervenes in completing questionnaire and post operation research process after supervisor professor, not knowing the prep process and betadine percentage. Since the examining professor and the patient are unaware of the percent of iodine use, the study is double blind.