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IRCT20171004036554N2 IRCT 2017-12-26 Tehran University of Medical Sciences Evaluation of the results of using two packing techniques in the repair of perforated tympanic membrane Evaluation of the results of middle ear packing using Gelfom in comparison with silastic sheet in the treatment of timpanoplasty 2017-11-22 anticipated 78 Complete https://irct.ir/trial/27837 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized clinical trial which uses blocking technique. Each block block contains 4 patients, as a result 20 arrangements are possible. In selection of blocks, table of randomizes numbers is used, Blinding description: The surgeon is not informed of the surgical technique until the middle of surgery when the packing material is delivered to the surgical team. Evaluation of results and examination of patients is performed by a second surgeon 3 months after the surgery. Therefore the surgeon is blind to the technique until the moment of surgery. Statistician and the patients are also blind. N/A Repairing techniques in perforated tympanic membrane. Intervention 1: Intervention group 1: Cartilage tympanoplasty using Gelfoam. Intervention 2: Intervention group 2: Cartilage tympanoplasty using Silastic sheet. Undecided - It is not yet known if there will be a plan to make this available
public ایلناز کاظمی
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1628 elnazkazemi64@gmail.com Tehran University of Medical Sciences scientific ِDr. Hamed Emami
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1628 hd_emami@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients who are candidate of COM unilateral cartilage tympanoplasty patients who volunteer to participate in this study no limit no limit Both History of sensory-neural hearing loss History of anatomic disorder of auditory system Patients who must undergo mastoidectomy Anterior perforation of TM history of otorrhea in the last 3 months H72 Perforation of tympanic membrane Treatment - Surgery Treatment - Surgery Intervention group 1: Cartilage tympanoplasty using Gelfoam Intervention group 2: Cartilage tympanoplasty using Silastic sheet Graft take. Timepoint: 3 months after the surgery. Method of measurement: physical examination using a microscope by the the surgeon. Hearing improvemnt. Timepoint: 3 month after the surgery. Method of measurement: Audiometry. Anatomical position. Timepoint: 3 months after the surgery. Method of measurement: physical examination using a microscope by the the surgeon. Tehran University of Medical Sciences Approved 2017-11-21 Ethics committee of Tehran University of Medical Sciences Central department of Tehran University of Medical Sciences, Intersection of Keshavarz blvd. and Qods St. , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)