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IRCT20200118046177N1 IRCT 2020-02-22 Shiraz University of Medical Sciences The effect of pre-operation Povidone-iodine irrigation on sensory neural hearing loss in Tympanoplasty The effect of pre-operation Povidone-iodine irrigation on sensory neural hearing loss in Tympanoplasty 2020-01-21 anticipated 60 Complete https://irct.ir/trial/45122 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2 Sensorineural Hearing Loss. Intervention 1: Intervention group: To disinfect the external ear 5%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. However the audiometry performed 6 months after surgery will be analyzed for practice. Intervention 2: Control group: To disinfect the external ear 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. However the audiometry performed 6 months after surgery will be analyzed for practice. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mohammadreza Khademalizadeh
ENT Department, Khalili Hospital, Khalili Street
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3629 1470 Khadem@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammadreza Khademalizadeh
ENT Department, Khalili Hospital, Khalili Street
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3629 1470 Khadem@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Normal mucosa The ear must be dry for at least one month before surgery and must be free of inflammation and infection. The size of the tympanic membrane rupture should be more than 50%. Normal ossicle status of ear. Age must be older than 18 years old Those who do not have cholesteatoma, granulation tissue, and tympanosclerosis plaque. 18 years no limit Both If the patient does not meet any of the above criteria will be excluded Age under 18 years old Those who got followed up for less than 6 months Smokers, diabetics, liver and kidney failure H90.5 Unspecified sensorineural hearing loss Treatment - Devices Treatment - Devices Intervention group: To disinfect the external ear 5%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. However the audiometry performed 6 months after surgery will be analyzed for practice. Control group: To disinfect the external ear 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. However the audiometry performed 6 months after surgery will be analyzed for practice. Sensory Neural Hearing Loss. Timepoint: Before Surgery And 6 Month After Surgery. Method of measurement: Pure Tone Audiometry Test. Shiraz University of Medical Sciences Approved 2019-12-28 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Science Central Building, Zand Street Shiraz Fars Iran (Islamic Republic of)