Protocol summary

Summary
In this study 200 patients that are candidates for myringoplasty will be chosen and divided into two groups randomly. In group A 1gr sefazolin an hour before beginning of surgery and every 6 hours after surgery until 24 hours will be given to the patients and in visit of patients 1,2,4 and 8 weeks after surgery ,if no infection is seen, no antibiotics will be administered . in group B ,in addition to the mentioned protocol (1gr sefazolin an hour before beginning of surgery and every 6 hours after surgery until 24 hours and then), 500mg cephalexin capsule every 6 hours until 10 days will be given to the patients. Ear infections will be checked in first, second, forth and eighth week after surgery and results will be accumulated in checklists with all information of patients including age, sex, size of eardrum perforation (total, subtotal, half, lesser than half), duration of surgery, duration of dry ear before surgery (2 months, 2-6 months, 6-12 months, more than one year), tympanosclerosis, ear discharge, type and amount of used antibiotics.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105222821N5
Registration date: 2011-06-11, 1390/03/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Seyed Javad Seyed Toutounchi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 9435
Email address
totonchis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibiotic prophylaxis roles in success of myringoplasty in patients with eardrum perforation
Public title
Antibiotic prophylaxis roles in success of myringoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1.patients with eardrum perforation, 2. no discharge of ear for 2 months, 3.no other pathology in middle ear. Exclusion criteria: 1. patients with active ear discharge, 2. other pathology of middle ear, 3.systemic diseases such as diabetes, 4.no satisfaction of patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
516568
Approval date
2010-06-29, 1389/04/08
Ethics committee reference number
5/4/2393

Health conditions studied

1

Description of health condition studied
chronic otitis media
ICD-10 code
H65
ICD-10 code description
Nonsuppurative otitis media

Primary outcomes

1

Description
eardrum healing
Timepoint
8 weeks
Method of measurement
examination and audiometry

Secondary outcomes

1

Description
infection of ear
Timepoint
1, 2, 4, 8 weeks
Method of measurement
examination and otoscopy

Intervention groups

1

Description
Group A: 1gr. sefazolin 1 hour before beginning of surgery and every 6 hours after surgery until 24 hours
Category
Treatment - Drugs

2

Description
Group B: 1gr. sefazolin 1 hour before beginning of surgery and every 6 hours after surgery until 24 hours and then 500mg cephalexin capsule every 6 hours until 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyed Javad Seyed Toutounchi
Street address
ENT Department, Emam Reza Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Faculty of Medicine
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Atefe Nourmohamadi
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine
City
Tabriz
Postal code
516568
Phone
+98 41103347054
Fax
+98 41 1335 2076
Email
a.nourmohamadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Javad Seyed Toutounchi
Position
Otolaryngologist, Associate
Other areas of specialty/work
Street address
ENT Department, Emam Reza Hospital
City
Tabriz
Postal code
5165683743
Phone
+98 41 1334 7054
Fax
+98 41 1335 2076
Email
javadtotonchi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Javad Seyed Toutounchi
Position
Otolaryngologist, Aassociate
Other areas of specialty/work
Street address
ENT Department, Emam Reza Hospital
City
Tabriz
Postal code
5165683743
Phone
+98 41 1334 7054
Fax
+98 41 1335 2076
Email
javadtotonchi@tbzmed.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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