The effect of urinary catheter removal time on the incidence of urinary infection and satisfaction level in patients undergoing lower extremity fracture surgery
The effect of urinary catheter removal time on the incidence of urinary infection and satisfaction level in patients undergoing lower extremity fracture surgery
Design
In this research, 96 patients undergoing lower limb fractures surgery referring to Imam Khomeini Hospital and Bank Melli Iran Hospital will be selected using blocks (9 blocks) and divide into 3 groups.
Settings and conduct
Catheterization will be done in three intervention groups. After leaving the catheter in each group, urine culture and analysis will be performed to examine the urinary tract infection in patients. The study will be done in Imam Khomeini Hospital and Bank Melli Iran Hospital.The study is Double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18-60 years; Placement in the lower extremity surgery list
Exclusion criteria: urinary tract infection; common chronic diseases (ِDiabetes, Heart failure, Renal failure, Chronic Obstructive Pulmonary Disease); Multiple Trauma; other infections
Intervention groups
The study has 3 groups:
First intervention group: People who their urinary catheter exits 24 hours after catheterisation.
Second intervention group: People who their urinary catheter exits 48 hours after catheterisation.
Third intervention group: People who their urinary catheter exits 72 hours after catheterisation.
Main outcome variables
The incidence of urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180208038670N1
Registration date:2018-04-22, 1397/02/02
Registration timing:prospective
Last update:2018-04-22, 1397/02/02
Update count:0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Tahereh Haghparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 6522
Email address
shirinehaghparast1389@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-29, 1397/02/09
Expected recruitment end date
2018-07-31, 1397/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of urinary catheter removal time on the incidence of urinary infection and satisfaction level in patients undergoing lower extremity fracture surgery
Public title
The effect of urinary catheter removal time on the incidence of urinary infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 60 years
Placement in the lower extremity surgery list
absence of chronic underlying diseases (ِDiabetes, Heart failure, Renal failure, Chronic Obstructive Pulmonary Disease)
no urinary tract infection prior to catheterization
Exclusion criteria:
urinary tract infection
common chronic diseases (ِDiabetes, Heart failure, Renal failure, Chronic Obstructive Pulmonary Disease)
Multiple Trauma
other infections
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done by coding with letters A, B, C for division of the groups. The patient does not know about group method and does not know which group he/sh is located in .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Nursing and Midwifery Faculty and Faculty of Rehabilitation
Street address
Nursing and Midwifery Faculty, East Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4167
Health conditions studied
1
Description of health condition studied
urinary infection
ICD-10 code
T83.0
ICD-10 code description
Mechanical complication of urinary (indwelling) catheter
Primary outcomes
1
Description
The incidence of urinary tract infection
Timepoint
during catheterization and 72 hours after catheterization.
Method of measurement
Culture and urine analysis
Secondary outcomes
1
Description
Patient satisfaction with urination
Timepoint
72 hours after catheterization, and when the patient experienced at least one voluntarily urination after catheter removal.
Method of measurement
patient satisfaction questionnaire
Intervention groups
1
Description
First intervention group: People who their urinary catheter exits 24 hours after catheterisation.
Category
Prevention
2
Description
Second intervention group: People who their urinary catheter exits 48 hours after catheterisation.
Category
Prevention
3
Description
Third intervention group: People who their urinary catheter exits 72 hours after catheterisation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Tahereh Haghparast
Street address
Imam Khomeini Hospital Complex, The end of Keshavarz boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6658 1615
Email
shirinehaghparast1389@yahoo.com
2
Recruitment center
Name of recruitment center
Bank Melli Iran Hospital
Full name of responsible person
Tahereh haghparast
Street address
Bank Melli Iran Hospital, Ferdowsi street, Terhran
City
Tehran
Province
Tehran
Postal code
1135933763
Phone
+98 21 6142 0000
Fax
+98 21 6673 5210
Email
shirinehaghparast1389@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6119 0000
Email
shirinehaghparast1389@yahoo.com
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Haghparast
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
shirinehaghparast1389@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arpi Manukyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
ar-manookian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tahereh Haghparast
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, East Nusrat Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
shirinehaghparast1389@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes' data, including testing, interventions and results of intervention will be shared.
When the data will become available and for how long
Access starts after the publication of the results.
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
Presenting a Introduction letter from the University