The effect of ciprofloxacin powder accompanying with topical betamethasone compare to ciprofloxacin drop accompanying with betamethasone drope in the treatment of bacterial external otitis
Comparison of two methods of treatment, ciprofloxacin powder with betamethasone ointment compare to ciprofloxacin drops with betamethasone drop in the treatment of bacterial infection of the external ear after suction clearness.
Design
120 patients with external ear infections who are eligible for inclusion in the study are selected. Participants are randomly divided into intervention and control groups (the same as the usual medicine).
Settings and conduct
Patients who referred to the ENT clinic of Rouhani Hospital of Babol, were randomly divided into two groups of 60 persons (which can be identified with a 95% confidence interval and 80% test power of 0.5 unit difference between the groups statistically. ), In group one, after suction clearance, ciprofloxacin powder with betamethasone ointment will be used and , after suction clearance, ciprofloxacin drops with betamethasone drop in the ear canal of second group were used.
Participants/Inclusion and exclusion criteria
The presence of infection in the external ear and the patient's desire to appear in the study as a inclusion, and ear tympanic rupture, mixed infection and reluctance to attend are as exclusion criteria.
Intervention groups
Cotrol group: Ciprofloxacin drop with betamethasone drop
Case group: Ciprofloxacin powder with betamethasone ointment
Main outcome variables
Pain, Swelling, Secretion and Itching.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130427013136N5
Registration date:2018-06-27, 1397/04/06
Registration timing:registered_while_recruiting
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Saeid Mahdavi Omran
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9936
Email address
s.mahdavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ciprofloxacin powder accompanying with topical betamethasone compare to ciprofloxacin drop accompanying with betamethasone drope in the treatment of bacterial external otitis
Public title
The effect of ciprofloxacin and betamethasone in the treatment of otitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suspected of external bacterial infection
Exclusion criteria:
Patients with the rupture of the tympanic membrane
Patients with mixed infection
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Each person is randomly assigned to one of two groups using a random number table.The status of each person is related to secretary of the department.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the initial code for each patients, the physician and the laboratory staff are not aware from of each group.
Placebo
Not used
Assignment
Parallel
Other design features
According to the presence of Ciprofloxacin tablet (FDA approved) in the drugstore, this drug is converted to powder by the pharmacologist for use on the patient. Due to the local application of the drug, there will be no side effects on the patient.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ettics committee of Babol University of Medical Sciences
Street address
Ganj Afrooz Ave
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
MUBABOL.HRI.REC.1396.201
Health conditions studied
1
Description of health condition studied
Bacterial of otitis externa
ICD-10 code
H62.0
ICD-10 code description
Otitis externa in bacterial diseases classified elsewhere
Primary outcomes
1
Description
The change degree of ear itching
Timepoint
Evaluation of the therapeutic effect of the two drugs occurs after 2 weeks.
Method of measurement
The question of the patient about the itching can be helpful.
2
Description
The pain in the ears (VAS)
Timepoint
Evaluation of the therapeutic effect of the two drugs occurs after 2 weeks.
Method of measurement
We will use from A 10-point VAS to measure pain.
3
Description
Change the secretion rate of swelling
Timepoint
Evaluation of the therapeutic effect of the two drugs occurs after 2 weeks.
Method of measurement
These variables are evaluated based on the physician's observations of the ear.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ciprofloxacin powder accompanying with topical betamethasone will be use in the outer ear space, using insuflation and soab, respectively.
Category
Treatment - Drugs
2
Description
Control group: Ciprofloxacin drop and betamethasone drop will be use in the outer ear space.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani, Babol
Full name of responsible person
Dr. Keyvan Kiakojouri
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
kia_ko13358@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Saeid Mahdavi Omran
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
s.mahdavi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Keyvan Kiakojouri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
kia_ko133358@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
s.mahdavi@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD