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Comparison of two preoperative asepsis methods with 10% Povidone Iodine alone and 10% Povidone Iodine sequences followed by 70% Ethanol on the microbial load of surgery area and bacterial identification in patients who are candidates for open heart surgery

Protocol summary

Study aim
Comparison of the effect of two prep methods with betadine 10% alone and the sequence of betadine 10% and then ethanol 70 ° on the microbial load and mass of the operation site in patients candidates for open heart surgery
Design
Clinical trial with control group, with parallel group, double-blind, simple randomized and on 90 patients
Settings and conduct
This study is a double-blind clinical trial that will be performed on 90 patients who are candidates for open heart surgery at Afshar Hospital of Yazd University of Medical Sciences. This study is designed in such a way that patients do not know the type of medication used to disinfect the operating area and also physicians do not know what group each patient belongs to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for heart surgery، No infectious skin diseases، No allergies to antiseptics، People with diabetes Exclusion criteria: The patient's unwillingness to continue cooperation، Negative results of culture before primary prep in both groups
Intervention groups
In all patients, nasal sampling is performed to determine the carriers of Staphylococcus aureus. In one group of patients, 10% betadine sequence and then alcohol are used to disinfect the operative area, and in the other group, only 10% betadine is used. At the end of the operation, deep sampling will be performed in all patients.
Main outcome variables
microbial mass of the operating area and nose, microbial load of the operating area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201201049562N1
Registration date: 2020-12-22, 1399/10/02
Registration timing: registered_while_recruiting

Last update: 2020-12-22, 1399/10/02
Update count: 0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Mohammad Ali Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3629 9121
Email address
mm.9872ali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two preoperative asepsis methods with 10% Povidone Iodine alone and 10% Povidone Iodine sequences followed by 70% Ethanol on the microbial load of surgery area and bacterial identification in patients who are candidates for open heart surgery
Public title
Comparison of disinfection effect with two methods of using betadine alone and sequence of betadine and then alcohol on the number and type of microbes in the operation area
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for heart surgery No infectious skin diseases No allergies to antiseptics People with diabetes
Exclusion criteria:
The patient's unwillingness to continue cooperating Negative culture results before primary prep in both groups
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
More than 1 sample in each individual
Number of samples in each individual: 5
The frequency of microbial sampling consists of three steps: before prep, sampling will be performed from the operation area and also from the patients' noses to determine the carriers of Staphylococcus aureus. After prep, sampling from the operation area will be done in both groups and to compare the durability of the disinfectant solution at the end of the operation, sampling will be done again in both groups from the wound depth of the operation area.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed so that patients have no knowledge of the type of substance used to disinfect the operating area, and physicians have no knowledge of what group each patient falls into.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Imam Jafar Sadegh Boulevard towards Mahdieh Square, Mahdieh 2 dead end, Teachers ComplexImam Jafar Sadegh Boulevard towards Mahdieh Square
City
Yazd
Province
Yazd
Postal code
8916795597
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.SSU.SPH.REC.1399.037

Health conditions studied

1

Description of health condition studied
Microbial load and mass of the operating area
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Microbial load and mass of the operating area
Timepoint
Before disinfection of the operation area, after disinfection of the operation area, at the end of the operation
Method of measurement
Use of mannitol salt agar, blood agar, eosin methylene blue agar media and differential media

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, 10% betadine sequence and then 70 ° ethanol or 70% alcohol are used to disinfect the operation area.
Category
Prevention

2

Description
Control group: In this group, 10% betadine alone is used to disinfect the operating area.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Mohammad Ali Mansouri
Street address
Jomhory Boulevard, Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 5014
Email
mm.9872ali@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Ali Mansouri
Street address
Bahonar Square, the central building of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Sadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
bacteriology
Street address
Imam Hossein Square, at the beginning of Daneshjoo Boulevard, after the Governor's Office, Imam Reza Educational and Research Complex, School of Paramedical Sciences
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3623 8505
Email
sadeh_m20@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Sadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
bacteriology
Street address
Imam Hossein Square, at the beginning of Daneshjoo Boulevard, after the Governor's Office, Imam Reza Educational and Research Complex, School of Paramedical Sciences
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3623 8505
Email
sadeh_m20@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Sade
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Bacteriology
Street address
Imam Hossein Square, at the beginning of Daneshjoo Boulevard, after the Governor's Office, Imam Reza Educational and Research Complex, School of Paramedical Sciences
City
Yazd
Province
Yazd
Postal code
8916188635
Phone
+98 35 3623 8505
Email
sadeh_m20@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
All data will potentially be shared after identifying individuals.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutes of medical sciences
Under which criteria data/document could be used
All researchers working in academic and scientific institutes of medical sciences in the country can access the published results of the study.
From where data/document is obtainable
Dr. Maryam Sadeh, sadeh_m20@yahoo.com
What processes are involved for a request to access data/document
The applicant can submit his/her application via email to be reviewed.
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