According to produce of infection in ear canal after removal of cerumen, the aim of this study is prevention or decrease of otitis external and also elimination of additional cost after removal of cerumen. Thus all Patients referred to Rohani Hospital, Babol, Iran, with cerumen in air canal will enter in this study, after Microscopial examination (without any inflammation and infection). All remaining patients will divided to case and control groups as randomized, 100 persons, totally. After suction all plug in air canal (for each group), in case group, they receive boric acid 2% by soab and then Miconazole cream 2%. )we do not use any drugs for control group).All of patients follow for 1 week.
General information
Acronym
prevention of ear infection
IRCT registration information
IRCT registration number:IRCT201104176208N1
Registration date:2011-11-04, 1390/08/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-11-04, 1390/08/13
Registrant information
Name
Keyvan Kiakojori
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9936
Email address
kiakojuri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prevention of ear canal infection with or without using boric acid and miconazole after suction
Public title
The effect of boric acid and miconazole in prevention of ear infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All persons with cerumen in air canal
Exclusion criteria: Pain; Inflammation; Bacterial and Fungal infections; Systemic infection; Media chronic otitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afroos St.
City
Babol
Postal code
4717647745
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
3150/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Pateints with abnormality in hearing, and to need washing
ICD-10 code
H60
ICD-10 code description
Otitis externa
Primary outcomes
1
Description
Prevention of infflamation and pain in air canal
Timepoint
24 hrs and after 1 week
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Pateint satisfaction from hearing
Timepoint
After 1 week
Method of measurement
Clinical examination
Intervention groups
1
Description
Case group: After suction all plug in air canal under microscopical guides, they will receive boric acid 2% by soab and then Miconazole cream 2%. They follow for 1 week. We propose they use boric acid 2% after each bath and without any use soab and prevention of water entry.
Category
Prevention
2
Description
Control group: After suction all plug in air canal under microscopical guides, we do not use any drugs. They follow for 1 week. We propose they use boric acid 2% after each bath and without any use soab and prevention of water entry.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aytollah Roohani Hospital, Babol
Full name of responsible person
Dr. Keyvan Kiakojori
Street address
Aytollah Rohani Hospital,Ganj Afrooz St., Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganj Afroos St., Babol
City
Babol
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol Univerity Of Medical Sciences
Full name of responsible person
Dr. Keyvan Kiakojori
Position
Associated Professor
Other areas of specialty/work
Street address
Ganj Afrooz st., Ayatollah Roohani Hospital
City
Babol
Postal code
Phone
+98 11 1219 9936
Fax
+98 11 1219 9936
Email
k.kiakojoori@mubabol
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Keyvan Kiakojori and Dr. Saeid Mahdavi Omran
Position
Associated Profesor and Assistant Professor, respectively