Comparison of Effect of Betadine and Chlorhexidine for periurethral cleaning before Catheterization on Bacteriuria and pyuria in female patients hospitalized in emergency of Alzahra hospital of Isfahan University of Medical Sciences 2018
Comparison of Effect of Betadine and Chlorhexidine for periurethral cleaning before Catheterization on Bacteriuria and pyuria in female patients hospitalized in emergency .
Design
This study was a single-blind clinical trial. Samples from hospitalized women in the emergency department were selected by random sampling and divided into two groups of 36, chlorhexidine and betadine.The perineal area and the urinary tract were washed with the Antiseptic. A urin sample was taken immediately after catheterization and 72 hours and 5 days after catheterization.The bacteriuria, pyuria and microorganism count were obtained from the test results.
Settings and conduct
Samples from hospitalized women in emergency department of university hospital were selected by random sampling and divided into two groups .The perineal area and the urinary tract were washed with the Antiseptic. A urin sample was taken immediately after catheterization and72 hours and 5 days after catheterization.The bacteriuria, pyuria and microorganism count were obtained from the test results.
Participants/Inclusion and exclusion criteria
In this study, female patients 18 years of age who need Foley catheter for 5 days can be evaluated with their satisfaction. Patients who are admitted with the Foley catheter and diagnosed with urinary tract infections and on the other hand A history of hypersensitivity to the two solutions used in the intervention report are not included in the study.
Intervention groups
In this study, the effect of betadine and chlorhexidine in washing the perineal area and the urethra before the catheter is admitted female patients, in order to determine the effect of each of them in reducing the bacterial and pyuria of the Foley catheter.
Main outcome variables
Bacteriuria and pyuria in urine specimens
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170712035044N2
Registration date:2019-07-20, 1398/04/29
Registration timing:retrospective
Last update:2019-07-20, 1398/04/29
Update count:0
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7544
Email address
somayehghafari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-05, 1397/11/16
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2019-02-09, 1397/11/20
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
Comparison of Effect of Betadine and Chlorhexidine for periurethral cleaning before Catheterization on Bacteriuria and pyuria in female patients hospitalized in emergency of Alzahra hospital of Isfahan University of Medical Sciences 2018
Public title
Antiseptic effect on bacteriuria of patients with catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients need a Foley catheter for at least 5 days.
There is no obvious tissue damage to the mucosa and skin of the genital area in the patient.
There are no symptoms of urinary tract infection including fever above 38 °, pain in the suprapubic area, frequent urination, burning in the urine.
Absence of foley catheter at admission
No history of hypersensitivity to betadine and Chlorhexidine substances.
Exclusion criteria:
Unwillingness of the patient and family to continue participating in the study.
Need to leave the patient's catheter sooner than 5 days
Age
From 18 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the sampels divided into two intervention groups A and B by using random numbers and Randomizer software. group A with iodine and group B with Chlorhexidine was done periurethral cleaning before Catheterization .
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher specifies the type of solution in each group and at the time of sampling the participant is asked about the susceptibility to both solutions, but at the time of the intervention the participant is not aware of the type of solution used.(One-way blind to the patient)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Tehran-Ghods Town (West) - Between South Falamak and Zarafshan, Iran's Sims Avenue-Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor
City
Esfahan
Province
Isfehan
Postal code
۸۱۴۵۵۶۱۸
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
1397.378.IR.MUI.RESEARCH.REC
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
Primary outcomes
1
Description
Bacteriuria in patients with Foley catheter
Timepoint
Immediately after catheterization, bacteriuria were evaluated 72 hours and 5 days after catheterization.
Method of measurement
By sending a urine test and culture the urine in the Blood Agar environment.
2
Description
pyuria in patients with Foley catheter
Timepoint
Immediately after catheterization, pyuria were evaluated 72 hours and 5 days after catheterization.
Method of measurement
By sending a urine test and culture in the Blood Agar environment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, 36 female patients needed Foley Catheter and conditions for entry into the study, the urethra and perinea area were washed with iodine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later.
Category
Prevention
2
Description
Intervention group2: Intervention group 1: In this group, 36 female patients needed Foley Catheter and conditions for entry into the study, the urethra and perinea area were washed with Chlorhexidine, and the urine specimen in the 3 periods immediately after the catheter was 72 hours Next and 5 days later.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital affiliated to Isfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Bldg No. 4, Isfahan University of Medical Sciences and Health Services.Vice-Chancellery for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Somaye Ghafari
Position
Assistant Professor of Nursing Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Assistant Professor, Faculty of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
HezarJarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Ghafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Nursing and Midwifery Faculty
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7544
Email
somayehghafari@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patient information
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