Comparison of the transparent dressing and impregnated dressing with chlorhexidine 2% on the colonization at the site of central venous catheter in patients hospitalized in intensive care unit
Comparison of the transparent with gauze dressing impregnated with chlorhexidine 2% on the colonization at the site of central venous catheter in patients hospitalized to the intensive care unit
Design
A randomized, controlled trial. The block method was used for randomization.
Settings and conduct
This study will be performed in Shahid Chamran Hospital in Boroujerd and on patients hospitalized to the intensive care unit. Samples are randomly divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 60 years, lack of known infection in any part of the body.
Exclusion criteria: Lack of known infection in any part of the body.
Intervention groups
Intervention group: For patients in the intervention group, a transparent dressing impregnated with 2% chlorhexidine solution produced by Morvabon company will be used. The dressing is transparent, impermeable to moisture and made of polyurethane with dimensions of 10. 10 cm. The transparent dressing will be changed every 4 days.
Control group: In the control group, sterile gauze with dimensions of 10 × 10 cm impregnated with 2 ml of chlorhexidine solution will be used in similar conditions. The gauze dressing will be changed every day.
Main outcome variables
Microbial colonization at the site of the central venous catheter.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210408050900N1
Registration date:2021-06-15, 1400/03/25
Registration timing:registered_while_recruiting
Last update:2021-06-15, 1400/03/25
Update count:0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Majid Goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4231 3904
Email address
m.goudarzi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the transparent dressing and impregnated dressing with chlorhexidine 2% on the colonization at the site of central venous catheter in patients hospitalized in intensive care unit
Public title
The effect of chlorhexidine dressing on the colonization at the site of central venous catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 60 years
Lack of known infection in any part of the body
Exclusion criteria:
Dissatisfaction of the patient or family to participation in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
To generate the random sequence, permutation block randomization will be used. At first, 6 blocks will constructed as "ABBA, BAAB, AABB, BBAA, BABA, ABAB", then these blocks are arranged using a random number table, and individuals will assigned to two groups according to A and B letters.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2021-04-28, 1400/02/08
Ethics committee reference number
IR.ARAKMU.REC.1400.015
Health conditions studied
1
Description of health condition studied
Microbial colonization of the central venous catheter entry site
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Number of bacteria at the site of central venous catheter
Timepoint
At the beginning of the study (before the intervention) and 4 days after dressing
Method of measurement
Sabroud Dextrose Agar culture medium
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients in the intervention group, a transparent dressing impregnated with 2% chlorhexidine solution produced by Morvabon company will be used. The dressing is transparent, impermeable to moisture and made of polyurethane with dimensions of 10. 10 cm. The dressing will be changed every 4 days.
Category
Prevention
2
Description
Control group: In the control group, sterile gauze with dimensions of 10 × 10 cm impregnated with 2 ml of chlorhexidine solution will be used in similar conditions. The gauze dressing will be changed every day.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Afsane Amam Dost
Street address
Daneshgah St., Fatemi St.
City
Boroujerd
Province
Lorestan
Postal code
6813833946
Phone
+98 66 4251 4001
Email
publicrelation@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3505
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Majid Goudarzi
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
majidgoodarzi1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Majid Goudarzi
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
majidgoodarzi1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Majid Goudarzi
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
majidgoodarzi1365@gmail.com
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
It is provided unrecognizably at the request of individuals.
When the data will become available and for how long
The access period will start after the results are printed.
To whom data/document is available
Researchers at other Universities are allowed access.
Under which criteria data/document could be used
Documentation is provided in order to know how the work is done and to critique it.
From where data/document is obtainable
Majid Goudarzi
majidgoodarzi1365@gmail.com
What processes are involved for a request to access data/document
After stating the purpose of accessing the information, the requested items will be sent via email.