Comparing Effect of Washing Meatus Urinary Region with Chlorhexidine and Poidon Iodine Solutions on Level of Appearance of Bacteriuria in Patients with Fixed Urinary Catheter Infected CVA Hospitalized in Neuro-Internal Ward
. This study aims to examine effect of washing meatus urinary region with Chlorhexidine and Poidon Iodine solutions on level of appearance of bacteriuria in patients with fixed urinary catheter infected CVA who are hospitalized in Neuro-Internal Ward.
Methodology: This study was clinical study.75 of patients suffering CVA which 24 had passed from their cathetring and hospitalized in Neuro-Internal Ward, were placed in 3 groups of 25 through random blocking. The Meatus region of two groups with Chlorhexidine and Poidon Iodine and witness group with daily Normal Salin control group, 5mintues for maximum 10days, were washed. Samples were taken tests and culturing urine in days 1-5 and 10.In order to collect datas, demographic information questionnaire and NIHSS measurement were used. The results were valid and its reliability was 0.9
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302061407N5
Registration date:2013-03-04, 1391/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-04, 1391/12/14
Registrant information
Name
Jalil Azimian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 7267
Email address
jazzimian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effect of Washing Meatus Urinary Region with Chlorhexidine and Poidon Iodine Solutions on Level of Appearance of Bacteriuria in Patients with Fixed Urinary Catheter Infected CVA Hospitalized in Neuro-Internal Ward
Public title
Effect of Washing Meatuson on Level of Appearance of Bacteriuria in Patients with Fixed Urinary Catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: every patient should be Catheterized 24 hours ago; they must be admitted in Neurology ward; before admission, none of the subjects must not have urinary tract infections, or diseases that affect urine output such as renal failure etc; all of patients must suffer from CVA diseases; they must not have visible
urinary tract disease; patients in group one must not have a history of allergy to Chlorhexidine and patients in group two must not have a history of allergy to povidone iodine.
Exclusion criteria: if the samples of complete urine analysis and culture are positive on the first day (more than 100,000 colonies per milliliter in urine, or more than 3WBC/hpf in the samples; if the patient is carried out before the fifth day of intervention(before
taking the second sample); patients who don't consent to participate in the study were excluded; if patients show allergic reaction to any of the ingredients (povidone iodine / chlorhexidine) in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences Ethics Committee
Street address
Nursing Faculty- Qazvin University of Medical Sciences- Bahonar Blv- Qazvin
City
Qazvin
Postal code
Approval date
2012-07-23, 1391/05/02
Ethics committee reference number
6188/20/28
Health conditions studied
1
Description of health condition studied
Bacteriuria
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
2
Description of health condition studied
CVA
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Bacteriuria and pyuria of urine analysis
Timepoint
On the first, fifth and tenth days
Method of measurement
Colonies per milliliter of urine and ≥ 3 WBC / Hpf
2
Description
Positive urine culture
Timepoint
In the first, fifth and tenth days
Method of measurement
Urine analysis and urine culture
Secondary outcomes
1
Description
Demographic questionnaire
Timepoint
First day
Method of measurement
Questionnaire
2
Description
Scale NIHSS
Timepoint
First Day
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention Group: 25 patients in intervention group with chlorhexidine, daily, 5 minutes for up to 10 days of meatus region will be washed by using a sterile swab and a rotary washing will be performed.
Category
Prevention
2
Description
Control group: included 25 patients with daily Normal Salin, 5 mintues for maximum 10 days, were washed.Using a sterile swab and a rotary washing will be performed.
Category
Other
3
Description
Intervention group 2: 25 patients with Betadine will daily, 5 minutes for up to 10 days of meatus region will be washed .Using a sterile swab and a rotary washing will be performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Sina Hospital
Full name of responsible person
Yasin Azadmanesh
Street address
Neuro Internal Ward- Ali Sina Hospital- Naderi Cross- Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University Of Medical Sciences-nursnig and midwifery faculty-Vice-Chancellor for Research
Full name of responsible person
Dr fatemeh mohamadi
Street address
Vice-Chancellor for Research- Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University Of Medical Sciences-nursnig and midwifery faculty-Vice-Chancellor for Research
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
Qazvin University of Medical Sciences
Full name of responsible person
Yasin Azadmanesh
Position
M.A. student nursing
Other areas of specialty/work
Street address
Nursing Faculty- Qazvin University of Medical Sciences- Bahonar Blv- Qazvin
City
Qazvin
Postal code
Phone
+98 28 1333 8773
Fax
Email
yasinazadmanesh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jalil Azimian
Position
Member of the Academic Board of Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Nursing Faculty- Qazvin University of Medical Sciences- Bahonar Blv- Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 7267
Fax
Email
azzimianj@yahoo.com; jazzimian@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Yasin Azadmanesh
Position
M.A. student in nursing
Other areas of specialty/work
Street address
Nursing Faculty- Qazvin University of Medical Sciences- Bahonar Blv- Qazvin
City
Qazvin
Postal code
Phone
Fax
Email
yasinazadmanesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)