Protocol summary
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Study aim
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To evaluate the 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
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Design
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Phase 3, randomized control clinical trial with parallel group that performed on 80 patients. Randomization was done using random number table.
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Settings and conduct
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All patients had surgery by three expert surgeuon in Valiasr and Baqiyatallah hospital
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Participants/Inclusion and exclusion criteria
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Patients with chroim otitis media came to Valiasr and Bagiyatallah hospital who had undertaken tympanoplasty and tympanomastoidectomy at Valiasr hospital.
in the case of immune deficiency due to diabetes, HIV, oral corticosteroid use, History of cholesteatoma, Patient rejection and History of previous ear surgery, patients excluded.
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Intervention groups
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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. patients inthe control group received no drops.
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Main outcome variables
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Otorrhea, graft success, otitis externa, itching.
General information
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Reason for update
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To mention supervisor.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200728048241N1
Registration date:
2020-08-10, 1399/05/20
Registration timing:
retrospective
Last update:
2020-08-11, 1399/05/21
Update count:
1
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Registration date
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2020-08-10, 1399/05/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2013-03-21, 1392/01/01
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Expected recruitment end date
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2015-03-03, 1393/12/12
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Actual recruitment start date
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2013-03-21, 1392/01/01
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Actual recruitment end date
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2015-03-03, 1393/12/12
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Trial completion date
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2015-03-03, 1393/12/12
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Scientific title
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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
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Public title
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Effects of topical drops on the result of tympanoplasty or tympanomastoidectomy surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with chronic otitis media
indication for surgery
patient preference
Exclusion criteria:
Patients with immune deficiency due to diabetes, HIV, oral corticosteroid use
History of cholesteatoma
Patient rejection
History of previous ear surgery
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-06-06, 1394/03/16
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Ethics committee reference number
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86100023
Health conditions studied
1
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Description of health condition studied
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Chronic otitis media
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ICD-10 code
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H66.3
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ICD-10 code description
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Other chronic suppurative otitis media
Primary outcomes
1
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Description
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Otorrhea due to graft failure
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Timepoint
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Week 6 and week 12 after surgery
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Method of measurement
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Examination by microscope
2
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Description
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Tympanic membrane graft success
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Timepoint
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Week 6 and week 12 after surgery
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Method of measurement
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Examination by microscope
3
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Description
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Post surgery otitis externa
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Timepoint
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Week 6 and week 12 after surgery
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Method of measurement
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Examination by microscope
4
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Description
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Post surgery itching
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Timepoint
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Week 6 and week 12 after surgery
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Method of measurement
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Examination by microscope
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: In patients in this group, no topical drops, prescribes.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available