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IRCT20200728048241N1 IRCT 2020-08-10 Tehran University of Medical Sciences Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery in patients with chronic otitis media at valiasr and Baqiyatallah Hospital in 1392-1393 2013-03-21 anticipated 80 Complete https://irct.ir/trial/49984 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method using a table of random numbers used.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain even numbers for intervention group receiving topical drops and odd numbers for control group.Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups. 3 Chronic otitis media. Intervention 1: Intervention group: In the intervention group, after removal of dressing, patients received ciprofloxacin eye drop 0.3% 3 to 4 times a day and betamethasone eye drop 0.1% 3 to 4 times a day for a week. Intervention 2: Control group: In patients in this group, no topical drops, prescribes. 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 It is not yet known if there will be a plan to make this available
public Saman Rezaeian
No.10, Asia Building, Ghadiri Alley, Sandough adalat Ave.
Rasht Iran (Islamic Republic of) 4138646867 +98 13 3336 6182 s-rezaeian@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mahtab Rabbani Anari
Sa`adi St. Enghelab Ave.
Tehran Iran (Islamic Republic of) 6511111457 +98 21 6634 3352 m_rabani@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic otitis media indication for surgery patient preference no limit no limit Both Patients with immune deficiency due to diabetes, HIV, oral corticosteroid use History of cholesteatoma Patient rejection History of previous ear surgery H66.3 Other chronic suppurative otitis media Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, after removal of dressing, patients received ciprofloxacin eye drop 0.3% 3 to 4 times a day and betamethasone eye drop 0.1% 3 to 4 times a day for a week. Control group: In patients in this group, no topical drops, prescribes. Otorrhea due to graft failure. Timepoint: Week 6 and week 12 after surgery. Method of measurement: Examination by microscope. Tympanic membrane graft success. Timepoint: Week 6 and week 12 after surgery. Method of measurement: Examination by microscope. Post surgery otitis externa. Timepoint: Week 6 and week 12 after surgery. Method of measurement: Examination by microscope. Post surgery itching. Timepoint: Week 6 and week 12 after surgery. Method of measurement: Examination by microscope. Tehran University of Medical Sciences Approved 2015-06-06 The Ethics Committee of Tehran University of Medical Sciences Qods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)