The aim of this study was to determine the effect of Mupirocin Ointment and Chlorhexidine Gluconate Versus Normal Saline in the Prevention of Central Catheter Dialysis-Related Infections
Design
This study is a phase III randomized controlled trial involving 120 patients who will be allocated to three groups—two intervention groups and one control group—through randomization. In the control group, participants will receive normal saline. The two intervention groups will include one group receiving mupirocin and another receiving chlorhexidine, both of which will be applied to the site intended for dressing after each dialysis session before the dressing is placed. The incidence of infection associated with central venous catheterization will be assessed at intervals during the second, third, fourth, fifth, and sixth months.
Settings and conduct
This study is a randomized clinical trial involving a sample of 120 dialysis patients utilizing central catheters at educational hospitals affiliated with Qazvin University of Medical Sciences. These individuals are patients referred to the dialysis unit of the hospital. After each patient visit for dialysis, the trained nurse will administer the medication prior to dressing, depending on whether the patient is in the intervention or control group. The patient, the treating physician, and the individual conducting the analysis are all unaware of the type of intervention, ensuring a blind study design.
Participants/Inclusion and exclusion criteria
inclusion criteria: The patients who require a central venous catheter for dialysis
Exclusion criteria: Patients who use a temporary central venous catheter.
Intervention groups
In the intervention group, one group will receive a 2% mupirocin ointment, while another group will receive a 2% chlorhexidine solution in 70% alcohol
Main outcome variables
Infection Caused by the Use of Central Venous Catheter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241118063765N1
Registration date:2025-03-17, 1403/12/27
Registration timing:registered_while_recruiting
Last update:2025-03-17, 1403/12/27
Update count:0
Registration date
2025-03-17, 1403/12/27
Registrant information
Name
Amin Karampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
amin.karampour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-08, 1403/11/20
Expected recruitment end date
2025-12-11, 1404/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mupirocin Ointment and Chlorhexidine Gluconate Versus Normal Saline in the Prevention of Central Catheter Dialysis-Related Infections
Public title
Comparative Evaluation of the Effects of Mupirocin Ointment and Chlorhexidine Versus Normal Saline in the Prevention of Dialysis-Related Infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent obtained
Patients aged 18 years and older
Patients on dialysis with a central venous catheter
Ability and willingness to participate in the study and adhere to treatment protocols
Exclusion criteria:
Acute or chronic medical conditions that, in the opinion of the Principal Investigator (PI), may interfere with the assessment of the efficacy and/or safety of the study drug
Patients who have not received antibiotic treatment for a proven catheter infection in the past month
Patients who have not been treated with mupirocin or chlorhexidine in the past month
Patients with a history of previous severe allergic reactions or known drug allergies to any of the study treatments
Patients with a fistula or a temporary catheter (Shaldon catheter)
Patients undergoing routine dialysis for end-stage renal disease (ESRD) who have been hospitalized for any reason
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals were assigned to study groups using balanced block randomization methods with a block size of six. A random sequence was generated using online random generator websites
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin university of medical science
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34417431874
Approval date
2025-01-01, 1403/10/12
Ethics committee reference number
IR.QUMS.REC.1403.394
Health conditions studied
1
Description of health condition studied
Central Catheter Dialysis-Related Infections
ICD-10 code
T82.7
ICD-10 code description
Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
Primary outcomes
1
Description
The rate of central venous catheter infection in dialysis patients
Timepoint
Measurement of infection rate in the second week, third week, fourth week, second month, third month, fourth month, fifth month, and sixth month
Method of measurement
Positive blood culture results and/or fever above 38 degrees Celsius, or hypothermia below 36.5 degrees Celsius during dialysis, and/or cellulitis (swelling, warmth, redness, or purulent discharge around the central catheter)
Secondary outcomes
1
Description
Determining Length of Hospital Stay Due to Central Venous Catheter Infection in Three Groups
Timepoint
Second week, third week, fourth week, second month, third month, fourth month
Method of measurement
Patient Record
2
Description
Determining Medication Consumption Behavior in Intervention and Control Groups
Timepoint
Checklist
Method of measurement
Second week, third week, fourth week, second month, third month, fourth month
3
Description
The determination of changes in depression in two groups: intervention and control
Timepoint
Second week, third week, fourth week, second month, third month, fourth month
Method of measurement
Patient Health Questionnaire-2 (PHQ-2)
4
Description
The determination of changes in anxiety in two groups: intervention and control
Timepoint
Second week, third week, fourth week, second month, third month, fourth month
Method of measurement
Generalized Anxiety Disorder 2-item (GAD-2)
Intervention groups
1
Description
Intervention group: In this group, 2% chlorhexidine in 70% alcohol will be administered to individuals. Following each dialysis session, prior to catheter insertion, this solution will be applied by the nurse to the patient.
Category
Prevention
2
Description
Intervention group: In this group, mupirocin will be administered to individuals. Following each dialysis session, prior to catheter insertion, this medication will be administered by the nurse to the patient.
Category
Prevention
3
Description
Control group: Individuals in this group will receive normal saline. Following each dialysis session, prior to catheter insertion, this solution will be administered by the nurse to the patient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Amin Krampour
Street address
Qazvin University of Medical Sciences.Bahonar Blvd,Qazvin,
City
Qazvin
Province
Qazvin
Postal code
344143184
Phone
+98 28 3333 8034
Email
amin.karampour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hasan Taherahmadi
Street address
Qazvin University of Medical Sciences , Bahonar street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3441343184
Phone
+98 28 3333 6001
Email
Hasan_Taherahmadi@gmail.com
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
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
Qazvin University of Medical Sciences
Full name of responsible person
Amin
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Qazvin university of medical sciences., Bahona Blvd.
City
Qazvin
Province
Qazvin
Postal code
34146388588
Phone
+98 28 1223 7267
Email
amin.karampour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Minoodar Blvd., Velayat Hospital., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34146388588
Phone
+98 28 3333 6001
Fax
Email
amin.karampour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amin Karampour
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Minoodar Blvd., Velayat Hospital., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34146388588
Phone
+98 28 3333 6001
Fax
Email
amin.karampour@yahoo.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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
This only available for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
Researchers requiring access must submit formal requests outlining their intended use of the data, which will be reviewed by a data access committee or an institutional review board.
From where data/document is obtainable
Individuals can submit their formal requests to the following email address: “amin.karampour@yahoo.com”.
What processes are involved for a request to access data/document
The process for requesting access to data or documents involves several key steps that require careful attention and adherence to established protocols. Initially, the applicant must prepare a formal request outlining the purpose of the data access, the specific information needed, and its intended use, which may take 1-2 weeks. Following submission, the request undergoes an initial review by the data access committee or institutional review board (IRB), lasting 1-3 weeks, before a thorough evaluation is conducted, which can take an additional 2-4 weeks. The applicant is then notified of the decision, typically within a week.