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
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
Design
Clinical trial with Control Group, with Parallel Groups, Single Blind, Non-Randomized. Patients randomly selected by Physician Divided into Case and control groups and There are 50 People in each Group.
Settings and conduct
After referring Patients to the Physician Personal Clinic in Birjand City,First, the Diagnostic Measures are Taken for Them and if See Symptoms of Acute Otitis Externa They will be Included in the Study. The Patients were then randomly selected by Physician divided Into Two Control Groups: Topical Ciprofloxacin (TC) Drop alone and Case: TC Drop were combined with the Initial Application of Betadine Impregnated Mesh .
Participants/Inclusion and exclusion criteria
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.
Intervention groups
In Control Group after dropping Topical Ciprofloxacin (TC) Drop in the Ear and Suctioning for Patients only TC 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.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.
Main outcome variables
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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190913044761N1
Registration date:2019-11-01, 1398/08/10
Registration timing:registered_while_recruiting
Last update:2019-11-01, 1398/08/10
Update count:0
Registration date
2019-11-01, 1398/08/10
Registrant information
Name
Mohsen Izadmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 0737
Email address
mohsenizadmehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-27, 1398/02/07
Expected recruitment end date
2020-04-26, 1399/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Effect of Topical Ciprofloxacin Combined with the Initial Application of Betadine Impregnated Mesh in the Treatment of Bacterial Acute Otitis Externa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Diabetes
Immunodeficiency
Pregnancy
History of Trauma to the Ear
Ear Surgery
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.