Comparison of the effect of surgical site skin preparation with povidone-iodine antiseptic at two different temperatures on the microbial load and surgical site infection in laparotomy patients
Comparison of the effect of surgical site skin preparation with povidone iodine at two different temperatures
Design
clinical trial with control and intervention groups, with parallel groups, single-blinded, randomized and phase 3 on 126 patients. the table of random numbers made by the computer will be used for study randomization.
Settings and conduct
This study will be conducted in the operating room by taking microbial cultures from the surgical site skin in three stages; before surgical site skin preparation, after the primary stage and after the secondary stage of surgical site skin preparation. the incidence of surgical site infection in 24 hours and 30 days after the operation will be checked. In this study, the participants will not be informed about the temperature of the antiseptic solution used.
Participants/Inclusion and exclusion criteria
Absence of immune system deficiency and malignancy
Not being allergic to povidone-iodine antiseptic
Age 18 to 55 years
Elective surgery
No contamination of instruments or surgical field
Intervention groups
In the intervention group, the secondary stage of surgical site skin preparation will be performed with 10% povidone-iodine at a temperature of 35°C and in the control group at a temperature of 22°C .
Main outcome variables
povidone-iodine antiseptic at two different temperatures; microbial load; surgical site infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240212060966N1
Registration date:2024-02-21, 1402/12/02
Registration timing:prospective
Last update:2024-02-21, 1402/12/02
Update count:0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Diba Nikkhah dashtizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4600
Email address
nikkhahdiba@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of surgical site skin preparation with povidone-iodine antiseptic at two different temperatures on the microbial load and surgical site infection in laparotomy patients
Public title
Comparison of the effect of surgical site skin preparation with povidone-iodine solution at two different temperatures on the antimicrobial effect and surgical wound infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 years
Having at least a diploma degree
No diabetes
No history of laparotomy surgery
Body mass index less than 35
Absence of immune system deficiency and no use of immunosuppressive drugs
Absence of local infection near the surgical site or systemic infection
Not being allergic to povidone-iodine antiseptic
No history of malignancy and radiation therapy
Absence of severe skin rash at the surgical site
Not using broad-spectrum antibiotics within a month before going to the hospital
having Elective surgery
Exclusion criteria:
Emergency laparotomy surgery
Disruption in the surgical process that leads to the contamination of the instruments or the surgical field
immune system deficiency and using immunosuppressive drugs
having diabetes
allergic to povidone-iodine antiseptic
The presence of rashes and severe skin diseases at the surgical site
using broad-spectrum antibiotics within a month before going to the hospital
morbid obesity
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
126
More than 1 sample in each individual
Number of samples in each individual:
3
Microbial cultures will be taken from the skin of the abdomen at the surgical site in three stages before surgical skin preparation, after primary surgical skin preparation and after secondary surgical skin preparation.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization tool: using a table of random numbers made by the computer
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, single blinding will be used; So that the samples will not be informed about the antiseptic temperature used for them. But the researcher and the surgical team will know the antiseptic temperature used for each sample.
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
Faculty of allied medicine, Iran univarsity of medical sciences ,Hemmat highway, next to the milad tower, tehran, iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.IUMS.REC.1402.1008
Health conditions studied
1
Description of health condition studied
Surgical site infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Microbial load
Timepoint
microbial cultures will be taken in three stages before the surgical site skin preparation, after the initial stage of disinfection of the surgical site and after the secondary stage of disinfection of the surgical site with povidone-iodine 10%.
Method of measurement
taking microbial culture and counting microbial colonies 24 hours after incubation
2
Description
Surgical site infection
Timepoint
Observation and examination of the surgical wound after 24 hours and 30 days after surgery
Method of measurement
Observing and examining the surgical wound and entering the symptoms in the surgical site infection checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: surgical site Skin preparation will be done in two stages. At first, before starting the skin preparation process, a culture will be taken from the skin of the surgical site with a sterile swab. In this way, an initial culture sample will be taken using a wet swab soaked in physiological serum and the swab will be rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone-iodine 7.5% will be used at a temperature of 22 degrees Celsius. The skin preparation will be done in a circular manner from the center of the surgical incision to the periphery and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation,we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, a skin culture will be taken from the surgical site. The second culture sample will be taken using a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar medium. Then, in the secondary stage, povidone-iodine 10% will be used at a temperature of 35 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. In this way, the swab will be rubbed on the blood agar culture medium. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. The culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared.
Category
Prevention
2
Description
Control group: Surgical site skin preparation will be done in two stages. First, before starting the skin preparation process, a sterile swab will be taken from the skin of the surgical site. In this way, a primary culture sample will be taken using a wet swab dipped in physiological serum and rubbed on the blood agar culture medium. Then, in the initial stage of skin preparation, povidone iodine 7.5% will be used at a temperature of 22 degrees Celsius. Skin preparation will be done in a circular manner from the center of the surgical incision to the periphery, and this will be done with 3 separate sterile gauzes. After performing the initial stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Before starting the secondary stage, the second culture will be taken from the skin of the surgical site. Then, in the secondary stage, povidone-iodine 10% at 22°C will be used. The preparation of the skin will be done in a circular manner from the center of the surgical incision to the periphery by 3 separate gas sterilizers. After performing the secondary stage of skin preparation, we will wait for 5 minutes and then the antiseptic residue will be dried by a sterile cloth. Again, a culture will be taken from the skin of the surgical site with a sterile swab dipped in physiological serum. Then, the surgical site will be covered with sterile cloths and sterile plastic covers, and the surgical process will continue. Culture samples will be sent to the laboratory to determine the microbial load. 24 hours after the surgery, the dressing of the surgical site will be changed for the first time by the researcher and the relevant doctor. The surgical site will be observed and examined for signs of surgical site infection. The symptoms will be recorded in the researcher's form for recording surgical site infection symptoms. The patient will be trained. The form for recording the symptoms of surgical site infection will be provided to the patient so that he or she can check the surgical site within one month after the surgery and record the symptoms in the said form. Then at the end of 30 days of the said form will be collected by the researcher. Finally, two groups will be compared.
5th floor of the central headquarters, Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
Falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fardin Amiri
Position
Assistant Professor, Faculty member of the operating room group
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Paramedicine,Iran University of Medical Sciences, between the intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Shahid Hammat highway, next to milad tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
amiri.fa@iums.ac.ir
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, faculty member of operating room group
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Paramedicine,Iran University of Medical Sciences, between the intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Shahid Hammat highway, Tehran, Iran
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
Diba nikkhah dashtizadeh
Position
دانشجوی کارشناسی ارشد
Latest degree
Bachelor
Other areas of specialty/work
surgical technology
Street address
Faculty of Paramedicine, Iran University of Medical Sciences ,between the intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Shahid Hammat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4600
Email
nikkhahdiba@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data will be shared, such as information on the main outcomes.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Students, employees and researchers working in academic and clinical institutions and medical sciences
Under which criteria data/document could be used
Researchers working in academic institutions of medical sciences
From where data/document is obtainable
To access the data, refer to the person in charge of updating the project information.
Name and surname: Diba Nikkhah Dashtizadeh
Email address: nikkhahdiba@gmail.com
Contact number: 09163531396
What processes are involved for a request to access data/document
In order to access the data, correspond with the person in charge of updating the information of the project via e-mail, and if the thesis project supervisor approves, the project data will be available to the applicants.