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IRCT20190913044761N1 IRCT 2019-11-01 Birjand University of Medical Sciences The Effect of Topical Ciprofloxacin Combined with the Initial Application of Betadine Impregnated Mesh in the Treatment of Bacterial Acute Otitis Externa Comparison of Response to Treatment of Bacterial Acute Otitis Externa Using Topical Ciprofloxacin Alone and Topical Ciprofloxacin Combined with the Initial Application of Betadine Impregnated Mesh 2019-04-27 anticipated 100 Complete https://irct.ir/trial/42642 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The Participants in this clinical trial were randomly divided into two groups of Case and Control.Depending on their group, They will receive the appropriate treatment including Topical Ciprofloxacin alone in the Control group and Topical Ciprofloxacin Drop were combined with the Initial Application of Betadine Impregnated Mesh in the Case group.The principal Investigators, who include Specialist Physicians and General Medical Students, Randomly divide the Patients into Two Case and Control groups.Health Personnel Responsible for determining the Microbial Mass of the Patient's Ear are not aware of the Status of segmentation.The Data Collection and Outcome Assessors, Including Specialist Physicians and General medical students, Are aware of the Status of Patient segmentation But the Committee on Safety and Data Monitoring is not aware of the Status of Patient segmentation. 3 Bacterial Acute Otitis Externa. Intervention 1: Intervention group: In the Case group after washing with Betadin and suctioning, In addition to TC Drop in Patients' Ear, a Mesh coated whit Betadin is plased and They are told to remove the Mesh 12 hours later and then until the first visit on the Third Day Every 4 hours 4 Drops dropp Inside the Ear Involved. Intervention 2: Control group: In Control Group after dropping Topical Ciprofloxacin (TC) Drop in the Ear and Suctioning for Patients only Topical Ciprofloxacin drop Prescribed and They are told that until the First Visit on the Third Day Every 4 hours 4 Drops dropp Inside the Ear Involved. 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 I have not yet decided on this
public Mohsen Izadmehr
Doorplate 73, Hafez 6/1, Hafez Street, Moallem Blvd
Birjand Iran (Islamic Republic of) 9491879613 +98 51 5523 0737 mohsenizadmehr@gmail.com Birjand University of Medical Sciences scientific Mohammad Reza Mofatteh
Doorplate 73, Hafez 6/1, Hafez Street, Moallem Blvd
Birjand Iran (Islamic Republic of) 9491879613 +98 51 5523 0737 mohsenizadmehr@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) All Patients Over the Age of 10 Years Based on a Physician's Initial Clinical Diagnosis of Bacterial Acute Otitis Externa and Lack of Concomitant Diabetes, Immunodeficiency, Pregnancy History of Trauma to the Ear, or Ear Surgery. 10 years no limit Both Diabetes Immunodeficiency Pregnancy History of Trauma to the Ear Ear Surgery H60.399 Other infective otitis externa, unspecified ear Treatment - Drugs Treatment - Drugs Intervention group: In the Case group after washing with Betadin and suctioning, In addition to TC Drop in Patients' Ear, a Mesh coated whit Betadin is plased and They are told to remove the Mesh 12 hours later and then until the first visit on the Third Day Every 4 hours 4 Drops dropp Inside the Ear Involved. Control group: In Control Group after dropping Topical Ciprofloxacin (TC) Drop in the Ear and Suctioning for Patients only Topical Ciprofloxacin drop Prescribed and They are told that until the First Visit on the Third Day Every 4 hours 4 Drops dropp Inside the Ear Involved. Percentage of People with Bacterial Acute Otitis Externa. Timepoint: Investigation of catch of Bacterial Acute Otitis Externa at the beginning of the study and 3, 7 and 10 days after Prescription Topical Ciprofloxacin combined with the Initial Application of Betadine Impregnated Mesh. Method of measurement: Clinical diagnosis of Specialist Physician. Birjand University of Medical Sciences Approved 2019-02-25 Ethics committee of Birjand University of Medical Sciences Doorplate 73, Hafez 6/1, Hafez Street, Moallem Blvd Birjand South Khorasan Iran (Islamic Republic of)