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Prevalence of early post-ventilation tube otorrhea

Protocol summary

Summary
Objective of this study is to compare the post-tympanostomy otorrhea in three treatment groups (irrigation of middle ear with isotonic saline, oral amoxicillin, and ciprofloxacin drop) with controls. In a single blind prospective stage III randomized clinical trial multicentre (Dastghaib and Khalili hospitals of Shiraz and Hamedan Besat hospital), Five hundred thirty ears in who had tympanostomy tube (TT), insertion because of OME between April 2006 and March 2013 were included. An inclusion criterion was age, less than15 years. Also Candidacy for surgery was based on the guide line of American Academy Of Otolaryngology -Head & Neck Surgery. Exclusion criteria were: chronic sinusitis, cleft palate, craniofacial abnormalities, known SNHL, complication of otitis media, and age more than 15. Patients were randomized into 4 groups regarding the type of preventive therapy: In group isotonic saline the middle ear cavity was irrigated with isotonic saline. In group oral amoxicillin the patient received (oral amoxicillin) for 7 days. In antibiotic drop group the patient received ciprofloxacin drop for 3 days. Finally, the control group received no treatment. Our primary outcome was post-tympanostomy otorrhea which evaluated by an assessor physician by microscopic otoscopy within first 2 weeks ( 3 days, one week and two weeks) after operation. During operation the middle ear status documented in five groups: normal, congested mucosa, or secretory (mucoid, serous, or pussy) as secondary outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112315496N1
Registration date: 2014-01-13, 1392/10/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-13, 1392/10/23
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevalence of early post-ventilation tube otorrhea
Public title
Prevalence of early post-Ventilation tube otorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: any child undergoing TT placement for COME with and without undergoing concurrent adenoidectomy based on the guide line of American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS) on diagnosis and management of OME( May 2004) that included children with OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms. Exclusion criteria: allergy to penicillin; chronic sinusitis; children who had previously undergone myringotomy and/or tube insertion; cleft palate; sensory neural hearing loss; complications of otitis media; craniofacial dysmorphism; mucociliary clearance disorders; immunodeficiency and age more than 15 years old.
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 530
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2006-03-19, 1384/12/28
Ethics committee reference number
84-2745

Health conditions studied

1

Description of health condition studied
post-tympanostomy otorrhea
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post-tympanostomy otorrhea
Timepoint
3 day, one week, 2 weeks after operation
Method of measurement
Microscopic otoscopy

Secondary outcomes

1

Description
The middle ear status: normal, congested mucosa, or secretory(mucoid, serous, or pussy).
Timepoint
Intra-operative
Method of measurement
Microscopic otoscopiy

Intervention groups

1

Description
In the second intervention group, the patients receive oral antibiotic (amoxicillin, 50 mg/kg), three times a day for 7 days after operation.
Category
Treatment - Drugs

2

Description
In the first intervention group, the middle ear cavity of the patient is irrigates with isotonic saline until the sticky fluid cleared.
Category
Treatment - Other

3

Description
In the third intervention group, the patient recieves topical ciprofloxacin drop (ciplex, Sinadarou company ), 4 drops three times a day, for 3 days after operation.
Category
Treatment - Drugs

4

Description
The control group, receives no treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Dastgheib hospital
Full name of responsible person
Street address
City
Shiraz

3

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Street address
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand Street,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shiraz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of medical sciences
Full name of responsible person
Mohammad Faramarzi
Position
Associate professor of otolaryngology
Other areas of specialty/work
Street address
Department of Otolaryngology,Khalili hospital, Khalili Street,Shiraz
City
Shiraz
Postal code
Phone
+98 71 1629 1478
Fax
Email
Faramarzi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Center for Development of Clinical Studies of Nemazee hospital- Vice Chancellery of Research and Tec
Full name of responsible person
Sareh Roosta
Position
MSc of biostatistics
Other areas of specialty/work
Street address
Center for Development of Clinical Research of Nemazee Hospital, Nemazee Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1612 5323
Fax
Email
namazi_balini@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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