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Comparing the Effect of preoperative skin preparation with povidone-iodine and chlorhexidine-gluconate on the surgical site infection

Protocol summary

Study aim
The purpose of this study was to determine and compare the effect of skin preparation with povidone iodine and chlorhexidine gluconate on surgical site infection rate in laparotomy patients.
Design
clinical trial with control group, 70 participants, randomized by the time of admission, parallel groups.
Settings and conduct
Research environment were the selected Educational and medical centers of Iran university of medical science. After collection of preliminary data and getting consent, patients were transferred to operating room. they were put under general anesthesia and then skin preparation of surgical site was done by the researcher with standard rotational method in two steps for each group. Patients were blinded by not telling them about which group they were going to be divided in. Data analyzer was blinded by Assigning specific numbers to patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria consists of age between 18 to 55 years, minimum diploma degree, signing the consent form, no history of abdominal surgery. Exclusion criteria consists of the following: diabetes, body mass index more than 35, presence of immunodeficiency, administration of immunosuppressive drugs, presence of local infection near the surgical site or systemic infection, allergic reaction to antiseptics used in this study, history of malignancy, presence of severe skin rash near the surgical site, history of radiotherapy, administration of broad spectrum antibiotics less than 30 days before surgery, emergency surgery, any incidents that may contaminate the surgical field or surgical instruments.
Intervention groups
skin preparation of surgical site in the control group was done with povidone iodine antiseptic. skin preparation of surgical site in the intervention group was done with chlorhexidine gluconate antiseptic.
Main outcome variables
Surgical site infection rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220206053955N1
Registration date: 2022-03-15, 1400/12/24
Registration timing: retrospective

Last update: 2022-03-15, 1400/12/24
Update count: 0
Registration date
2022-03-15, 1400/12/24
Registrant information
Name
Arash Khajehvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 4148
Email address
arashkhajevand72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2021-04-21, 1400/02/01
Actual recruitment end date
2021-09-22, 1400/06/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Comparing the Effect of preoperative skin preparation with povidone-iodine and chlorhexidine-gluconate on the surgical site infection
Public title
Comparing the Effect of preoperative skin preparation with povidone-iodine and chlorhexidine-gluconate on the surgical site infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
participants age between 18 to 55 years old participants at least have a high school diploma no past history of abdominal surgery sign the consent form of this study
Exclusion criteria:
presence of diabetes mellitus Body mass index more than 35 presence of immunodeficiency administration of immunosuppressive drugs presence of local infection near the surgical site or systemic infection Allergic reaction to any of antiseptic agents history of Malignancy presence of Skin rash near the surgical site history of radiotherapy administration of broad spectrum antibiotics less than one month before surgery emergency surgery any disruption in surgical theater that may leads to contamination of surgical instruments or surgical field during the surgery
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was done with random number table made by computer. According to the random number table, each patient was given a specific number which only the researcher was aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzers were blinded to which antiseptic we used in study. however, surgeon and surgical team as well as the researcher knew about which antiseptics were used for patients because of their color.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.IUMS.REC.1400.013

Health conditions studied

1

Description of health condition studied
Surgical site infection, Antiseptic, Povidone Iodine, Chlorhexidine Gluconate, Skin Preparation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Surgical site infection
Timepoint
Surgical site infection rate in period of 30 days after surgery were compared in both groups.
Method of measurement
Data collection tools were demographic data forms and surgical site infection assessment forms

Secondary outcomes

empty

Intervention groups

1

Description
Control group: After the induction of general anesthesia, the first step of surgical site skin preparation (skin prep) was done with povidone iodine 7.5% solution for about 3-5 minutes by the researcher with standard rotational method. then the remains of antiseptic solution was cleaned with sterile towel. The second step of skin prep was done with povidone iodine 10% solution and the procedure was like the first step.
Category
Prevention

2

Description
Intervention group: After the induction of general anesthesia, the first step of surgical site skin preparation (skin prep) was done with chlorhexidine gluconate 2% / isopropyl alcohol 70% solution for about 3-5 minutes by the researcher with standard rotational method. then the remains of antiseptic solution was cleaned with sterile towel. The second step of skin prep was done with chlorhexidine gluconate 2% / isopropyl alcohol 70% solution and the procedure was like the first step.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Arash khajehvand
Street address
Valadi Street, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
Firouzgar@iums.ac.ir
Web page address
https://firoozgar.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fardin Amiri
Street address
Hemmat Highway, next to Milad Tower, Iran university of medical sciences, School of Allied Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
Amiri.Fa@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arash Khajehvand
Position
M.Sc. student
Latest degree
Master
Other areas of specialty/work
Surgical Technology
Street address
Kousar district, Third square, East basij boulevard, Salman street, Rahmat alley, Medical science complex, 1st block, 3rd floor
City
Qazvin
Province
Qazvin
Postal code
3471945166
Phone
+98 28 3377 4148
Email
arashkhajevand72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fardin Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Allied Medical Sciences, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
amiri.fa@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arash Khajehvand
Position
M.Sc. student
Latest degree
Master
Other areas of specialty/work
Surgical technology
Street address
Kousar district, Third square, East basij boulevard, Salman street, Rahmat alley, Medical science complex, 1st block, 3rd floor
City
Qazvin
Province
Qazvin
Postal code
3471945166
Phone
+98 28 3377 4148
Email
arashkhajevand72@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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