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: The effect of usage combination of Betadine 10%drop/ Levofloxacin drop the number of conjunctival bacterial colony culture preparation during cataract surgery

Protocol summary

Study aim
Determine effect of usage combination of betadine 10%drop/ levofloxacin drop before surgery on the number of conjunctival bacterial colony culture preparation during cataract surgery in Khalili Hospital affiliated to shiraz University of Medical Sciences
Design
clinical trail inclusive control group، group parallel، double blind- randomization
Settings and conduct
This randomized clinical trial will be performed in Khalili hospital, Shiraz, . After transferring the patients to the operating room, the first culture will be taken from the inferior conjunctival fornix using a swab. Then, the patients will be divided into two groups randomly. The first group will receive tetracaine drops, while the second group will receive tetracaine, betadine 10%, and levofloxacin drops. After general anesthesia, the second culture will be obtained from the inferior conjunctival fornix using a swab. All patients will receive betadine 10% drops and after three minutes, the third culture will be taken from the inferior conjunctival fornix using a swab. the fourth culture will be taken from the inferior conjunctival fornix using a swab at the end of the surgery.
Participants/Inclusion and exclusion criteria
inclusion criteria : Being scheduled for cataract surgery, not suffering from serious kidney diseases, not having infections in other body organs, aging above 50 years, not having consumed topical or systemic antibiotics over 10 days prior to the operation, being willing to take part in the research. Exclusion criteria :Suffering from diabetes and rheumatoid arthritis,having infections
Intervention groups
intervention groups :This group will receive tetracaine, betadine 10%, and levofloxacin drops. control groups:This group will only receive tetracaine and betadine drops.
Main outcome variables
The number of conjunctival normal flora bacterial colony

General information

Reason for update
Acronym
B and L
IRCT registration information
IRCT registration number: IRCT20190212042693N1
Registration date: 2019-07-24, 1398/05/02
Registration timing: retrospective

Last update: 2019-07-24, 1398/05/02
Update count: 0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
roghayeh rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3821 4644
Email address
rezaeero@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-26, 1397/11/06
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: The effect of usage combination of Betadine 10%drop/ Levofloxacin drop the number of conjunctival bacterial colony culture preparation during cataract surgery
Public title
The effect of usage combination of Betadine 10%drop/ Levofloxacin drop the number of conjunctival bacterial colony culture preparation during cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being scheduled for cataract surgery not suffering from serious kidney diseases not having infections in other body organs aging above 50 years not having consumed topical or systemic antibiotics over 10 days prior to the operation and being willing to take part in the research.
Exclusion criteria:
Suffering from diabetes disease Rheumatoid Arthritis having infection
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
premunted block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study all participates have not any information about kind of drop and also laboratory personnel have not any information about specimens
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
Zand Ave: Shiraz univercity Medical Science
City
shiraz
Province
Fars
Postal code
713451978
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.SUMS.REC.1398.011

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract

2

Description of health condition studied
Endophthalmitis
ICD-10 code
H44.1
ICD-10 code description
Other endophthalmitis

Primary outcomes

1

Description
The number of conjunctival normal flora bacterial colony
Timepoint
before intervention -after intervention-after than 3 minute- end of surgery
Method of measurement
growth bacteria under media blood

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groups:This group will receive tetracaine, betadine 10%, and levofloxacin drops.drops produces Finland .drops will obtains after enter patients into operating room
Category
Prevention

2

Description
Control groups: This group will only receive tetracaine and betadine drops. drops produces Iran
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Roghayeh rezaee
Street address
Kalili Ave: Khalili hospital
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3629 1833
Email
rezaeero@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
jamshid Eslami
Street address
zand Ave: Shiraz University of Medical Science
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3230 5413
Email
yarden@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
roghayeh rezaee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khalili Ave :Khalili hospital
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3629 1833
Email
rezaeero@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
roghayeh rezaee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
khalili Ave :khalili hospital
City
shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3629 1833
Email
rezaeero@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
roghayeh rezaee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
KhaliliAve:Khalili hospital
City
shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3629 1833
Email
rezaeero@sums.a1438845276c.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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