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IRCT2016083017413N16 IRCT 2016-09-12 Baqiyatallah University of Medical Sciences Evaluating effect of PRP-enriched gelfoam on healing of Tympanic membrane rupture Comparing the Effect of PRP-enriched Gelfoam and Conventional Gelfoam on the Healing of Chronic Tympanic Membrane Perforation; A Double-blind Randomized Clinical Trial 2016-09-22 anticipated 30 Complete https://irct.ir/trial/16027 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Tympanic Membrane Perforation. Intervention 1: After transferring the patient to operation room and before presence of surgeon, 8 ml of blood will be obtained from patient’s brachial vein in intervention group and will be stored in PRP kits (RegenKit BCT). Samples will be centrifuged in room’s temperature by 3000 rounds/min in 5 minutes then 3 ml of the resulting solution will be disposed from the top of the kit. Based on factory’s instruction, the remaining solution will be shaken for obtaining 1ml of high density and homogenous PRP. In the following, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and enriched with PRP in galipot. In control group gel foams will be impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin. Intervention 2: After transferring the patient to operation room and before presence of surgeon, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and will be impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin.
public Mohammad Hossein Khosravi
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8862 0826 dr.mhkhosravi@gmail.com Students' Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran scientific Masoumeh Saeedi
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8862 0826 m.saeedi67@gmail.com 1- Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Baqiyatallah Unive Iran (Islamic Republic of) patients with ages between 18 and 60 years old who were candidates for type I Tympanoplasty were enrolled in the study. Patients with active otorrhea, cholesteatoma, canal stenosis, TM perforation more than 5 mm, autoimmune and hematologic diseases, active neoplasm, immunosuppressive treatment and diabetes as well as smokers were excluded from the study. 18 years 60 years Both H72 Perforation of tympanic membrane Treatment - Surgery Treatment - Surgery After transferring the patient to operation room and before presence of surgeon, 8 ml of blood will be obtained from patient’s brachial vein in intervention group and will be stored in PRP kits (RegenKit BCT). Samples will be centrifuged in room’s temperature by 3000 rounds/min in 5 minutes then 3 ml of the resulting solution will be disposed from the top of the kit. Based on factory’s instruction, the remaining solution will be shaken for obtaining 1ml of high density and homogenous PRP. In the following, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and enriched with PRP in galipot. In control group gel foams will be impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin. After transferring the patient to operation room and before presence of surgeon, small (1 and 2- mm) and two large (1 to 2 mm more than size of perforation) gel foams will be prepared and will be impregnated with normal saline for blinding purpose. Then surgeon, who is not aware of added material to gel foams, will be paged to the OR. After convenient prep and drep 1 ml of Lidocaine 2% will be injected to ear canal using insulin syringe. Following anesthesia, sharp rosen will be used for trimming of TM perforation margins and gel foams will be put in the middle ear. Then one of the large gel foams will be located in middle ear, under TM, and another one will be fixed in ear canal on the TM. Ear canal will be filled with small gel foams and Tetracycline mesh and wound dressing will be done using one gauze and surgifix. After operation, patients will be visited in recovery room and will be discharged with oral cephalexin. Healing of Tympanic Membrane. Timepoint: 2 and 3 months after intervention. Method of measurement: Hook tool. Tympanic Membrane Rupture. Timepoint: Before Intervention. Method of measurement: Hook tool. Side Effects. Timepoint: 2 and 3 months after intervention. Method of measurement: History and Examination. Treatment Cost. Timepoint: After Intervention. Method of measurement: Receipt. Baqiyatallah University of Medical Sciences Approved 2015-10-26 Baqiyatallah University of Medical Sciences Nosrati Alley, Sheykh Bahaei Street, Mollasadra street, Vanaq Square, Tehran, Iran Tehran Iran (Islamic Republic of)