In hospitals one of the key actions is the reduction of infections related to the care measures, that in developed countries it gains special attention for patients health. Since catheter- associated urinary infection creates in 80% case as a consequence of urinary catheterisation, the prevention of these infections has an important role to reduce infections related to the treatment cares. Therefore, the present study aims to comparison of multi-modality catheterization on bacteriuria and catheter – associated urinary tract infections
This study is a randomized and controlled double blind clinical trial. 200 patients aged between 18- 75 that they need the (insertion) of urinary catheter (foly) put in four groups including catheterilzation in usual method (control) and catheterization with daily change of sterile urinary bag, and catheterization with designed sheath catheter and catheterization with candom catheter.
In each two groups, immediately after the insertion and during the time of removing the urethral catheter, the urine sample was collected in sterile method and was sent to laboratory in order to test bacteriuria.
The demographic information will made and collect by using the researcher made questionnaire and analysis by Spss 20 software and descriptive statistic tests (frequency) relative frequency, mean, and standard deviation (SD).
The comparison of multi-modality catheterization on bacteriuria and catheter – associated urinary tract infections
The comparison of multi-modality catheterization on bacteriuria and catheter – associated urinary tract infections
Public title
The comparison of multi-modality catheterization on bacteriuria and catheter – associated urinary tract infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusin criteria: all the patients that hospitalized with several reasons and needed the preparation for urethra (Foly) catheter; age between 18 to 75 years old.
Exclusin criteria: the positive urinary culture at first of the study; the surgery on urinary system and anti-biotic consumption.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
739
Health conditions studied
1
Description of health condition studied
UTI
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Bacteriuria
Timepoint
immediately before insertion the urethral catheter and, immediately before removing the urethral catheter,
Method of measurement
cfu/ml
Secondary outcomes
empty
Intervention groups
1
Description
In evacuated urinary bag group(usual method), The silicon urethral catheter was established with routine method and the usual way by using aseptic method, and the urinary bag was evacuated after each completion. immediately before insert urethral catheter and before removing the urethral catheter, the urinary sample with aseptic method from urinary catheter by using 10cc sterile syringe prepare and sent to the laboratory to investigate for bacteriuria in less than 30 minutes.
Category
Prevention
2
Description
In change urinary bag group, The silicon urethral catheter establish with aseptic method. Then, in each urinary bag completion, this bag was evacuated and changed daily. immediately before insert urethral catheter and before removing the urethral catheter, the urinary sample with aseptic method from urinary catheter by using 10cc sterile syringe prepare and sent to the laboratory to investigate for bacteriuria in less than 30 minutes.
Category
Prevention
3
Description
In condom catheter group, The condom catheter establish with aseptic method.Immediately before insert urethral catheter and before removing the urethral catheter, the urinary sample with aseptic method from urinary catheter by using 10cc sterile syringe prepare and sent to the laboratory to investigate for bacteriuria in less than 30 minutes
Category
Prevention
4
Description
In desighned catheter sheath group, The desighned catheter sheath establish with aseptic method.Immediately before insert urethral catheter and before removing the urethral catheter, the urinary sample with aseptic method from urinary catheter by using 10cc sterile syringe prepare and sent to the laboratory to investigate for bacteriuria in less than 30 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Kobra Noorian
Street address
Kashani Hospital, Parastar Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shahrekord University of Medical Sciences.
Full name of responsible person
Mahmmod Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
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, Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Faculty member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
Postal code
Phone
+98 38 3333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Faculty member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
Postal code
Phone
+98 38 3333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Faculty member
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
Postal code
Phone
+98 38 3333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)