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Comparison of the effect of dressing with mupirocin ointment and dressing with betadine and simple dressing in the prevention of the superficial surgical site infection in patients undergoing cesarean section: a randomized clinical trial.

Protocol summary

Study aim
Comparison of the effects of dressing with mupirocin ointment, dressing with betadine, and plain dressing in preventing superficial surgical site infection in patients undergoing cesarean section.
Design
A randomized, parallel-group, controlled clinical trial in which patients will be assigned to three groups using a block randomization method: dressing with mupirocin ointment (M), dressing with betadine-impregnated gauze (B) as the intervention group, and a control group that is a sterile gauze dressing (C) with a ratio of 1:1:1.
Settings and conduct
This study is conducted in Iran Hospital, Iranshahr, in 2 intervention groups and 1 control group. The surgical wound after surgery is examined on the second day by a clinical evaluator (student and project collaborator) in the ward, and after a week and on day 30, it is evaluated by sending photos and also by clinical interview. If an infection is suspected, it is referred to a specialist.
Participants/Inclusion and exclusion criteria
Pregnant mothers referring to the operating room of Iran Hospital, Iranshahr city with informed consent in 2025 ; having underlying diseases such as uncontrolled diabetes and severe anemia and patients with immunodeficiency and premature rupture of the membranes, patients with kidney transplants, heart diseases and patients' lack of consent for the intervention and patients with high BMI.
Intervention groups
This study involves three groups with different post-surgery wound dressings. Group 1 uses 2% mupirocin ointment, Group 2 uses 10% betadine, and Group 3 receives a standard sterile gauze dressing changed after 48 hours. Each method aims to evaluate wound healing and infection prevention effectiveness. The study compares outcomes of these distinct approaches to wound care.
Main outcome variables
The main variable of the study will be surgical site infection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250309065003N1
Registration date: 2025-04-11, 1404/01/22
Registration timing: registered_while_recruiting

Last update: 2025-04-11, 1404/01/22
Update count: 0
Registration date
2025-04-11, 1404/01/22
Registrant information
Name
Mosaddegh Balouch Lashari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3246
Email address
m.balouch@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-02, 1403/10/13
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dressing with mupirocin ointment and dressing with betadine and simple dressing in the prevention of the superficial surgical site infection in patients undergoing cesarean section: a randomized clinical trial.
Public title
Comparison of the effect of dressing with mupirocin ointment and dressing with betadine and simple dressing in the prevention of the superficial surgical site infection in patients undergoing cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All women who will undergo cesarean section surgery at Iran Hospital, Iranshahr, in 2025 informed consent pregnant mothers referring to the operating room of Iran Hospital, Iranshahr,
Exclusion criteria:
Having underlying diseases such as uncontrolled diabetes and severe anemia Patients with kidney transplants, heart disease, and patients with high BMI patients with immunodeficiency and premature rupture of membranes
Age
From 14 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be assigned to three groups using the block randomization method: dressing with mupirocin ointment (M), dressing with betadine-impregnated gauze (B) as the intervention group, and the control group, which is a sterile gauze dressing (C), with a ratio of 1.1.1. The blocks of this study are 6 (BB, MM, CC)) in which 16 states will be created. First, the possible states of these 6 letters within the blocks will be determined, and then the block numbers will be determined by simple randomness and using a table of random numbers. In this way, the type of intervention will be determined based on the desired letters with the number of each patient and will be kept in a master sheet. Finally, the intervention number of each patient will be entered on a sheet when they visit, and the type of intervention will be known at that moment. The continuous entry number of the patients will be entered on the envelope, respectively, and the type of intervention or control will be specified inside the envelope. Gradually, depending on the presence of eligible patients, the relevant envelope is returned, and the type of intervention that is inside the opaque envelope is determined.
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 Mazandaran University of Medical Sciences
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2025-01-01, 1403/10/12
Ethics committee reference number
IR.MAZUMS.REC.1403.493

Health conditions studied

1

Description of health condition studied
Surgical Site Infection
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
Infection
Timepoint
Second, seventh and thirtieth day
Method of measurement
It will be reviewed by sending a photo and also a clinical interview on one of the social platforms, and if an infection is suspected, it will be referred to a specialist doctor.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are dressed with 2% mupirocin ointment. After the surgery, a sterile gauze is soaked with 2% mupirocin ointment (distributed by Ferdows, Mohya Darou) and placed on the wound so that it covers the entire length of the wound.
Category
Prevention

2

Description
Intervention group: The dressing is with betadine, and after the surgery is complete, gauze soaked in 10% betadine is placed on the incision site.
Category
Prevention

3

Description
Control group: Patients are dressed with a regular dressing, and after cleaning the wound, sterile gauze will be placed on the wound, and the dressing will be changed after 48 hours.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Hospital
Full name of responsible person
Mosaddegh Balouch Lashari
Street address
Iran Hospital, 4th km of Bampour Road, Iranshahr, Sistan and Baluchestan
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Web page address
https://iranhospital.irshums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
pajhooheshi@mazums.ac.ir
Web page address
https://research.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mosaddegh Balouch Lashari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
University Complex of the Great Prophet (PBUH), 17th kilometer of Khazarabad, Farahabad Boulevard (Darya Road), Khazar Square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3354 3246
Fax
Email
m.balouch@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mosaddegh Balouch Lashari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
University Complex of the Great Prophet (PBUH), 17th kilometer of Khazarabad, Farahabad Boulevard (Darya Road), Khazar Square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3354 3246
Fax
Email
m.balouch@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mosaddegh Balouch Lashari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technology
Street address
University Complex of the Great Prophet (PBUH), 17th kilometer of Khazarabad, Farahabad Boulevard (Darya Road), Khazar Square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3354 3246
Fax
Email
m.balouch@mazums.ac.ir

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
The information and names of the individuals studied will be confidential, and the results of the study will be published with the consent of the relevant university organizations.
When the data will become available and for how long
Access period starts from 1404
To whom data/document is available
The results of the study will be published with the approval of the relevant university organizations.
Under which criteria data/document could be used
All information obtained from the hospital remains confidential, and the researchers are committed to maintaining the principle of confidentiality regarding data obtained from patient files. Only the results will be reported in general in the article, in accordance with the ethical guidelines for publishing research works, without including the patient's details and name.
From where data/document is obtainable
To receive data, please contact Amir Hossein Jamali at the following address and mobile number: Sari, 17th km of Darya Road, Prophet Azam Complex, Faculty of Paramedical Sciences Mobile: 09923845223
What processes are involved for a request to access data/document
The results of the study will be published with the approval of the relevant university organizations.
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