Determination and comparison of bacterial colony of hand, before, immediately after and one hour after scrub in four methods of betadine scrub, decosept, betadine decosept and decosept betadine
Design
All participants done scrub randomly in 4 ways; The randomization method is determined using random numbers for each person. In this way, it is determined randomly which scrub method each person should do for the first to fourth time.
Settings and conduct
In the operating room of Kosar Hospital, members of the surgical team who meet the inclusion criteria are selected and all of them scrub in all four ways. The order of scrub methods is determined randomly.
Participants/Inclusion and exclusion criteria
Member of the surgical team that scrubs
Complete satisfaction to participate in this study
Be the first scrub of the day.
Short and clean nails
Do not use antibiotics at least one week before interventions
Do not use nail polish during the study
Do not get skin disease and excessive sweating of the hands
Lack of skin sensitivity to disinfectants
Absence of skin dermatitis
Intervention groups
Betadine Scrub: Hand scrub with 10 cc of betadine
Decospet Scrub: Hand scrub with 10 cc of Decospet solution
Betadine Decospet Scrub: Scrub with 10 cc of betadine for 3 minutes and then soak your hands in 5 cc of Decospet solution
Betadine Decospet Scrub: Hand scrub with 10 cc of Decospet for 3 minutes and then soak your hands with 3 cc of Betadine solution
Main outcome variables
Colony forming unite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110430006342N12
Registration date:2021-08-14, 1400/05/23
Registration timing:prospective
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of four scrub methods on the bacterial colony of the hand
Public title
Comparison of four scrub methods on the bacterial colony of the hand
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Member of the surgical team that scrubs
Complete satisfaction to participate in this study
Short and clean nails
Be the first scrub of the day
Exclusion criteria:
Use antibiotics at least one week before interventions
Use nail polish during the study
Skin disease and excessive sweating of the hands
Skin sensitivity to disinfectants
Skin dermatitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
12
Before, immediately after and one hour after scrub, hand sampling is done
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University of Medical Sciences and Health Services
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.SEMUMS.REC.1400.100
Health conditions studied
1
Description of health condition studied
Bacterial colony
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Colony forming unite
Timepoint
Before, immediately after and one hour after scrub
Method of measurement
Sampling and culture in laboratory environment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Betadine scrub. Hand scrub with 10 cc of betadine (Povidone iodine 7.5% made by Aria company for 3 minutes and rinsing them
Category
Prevention
2
Description
Intervention group: Decosept scrub. Hand scrub with 10 cc of decosept solution (made by Samen Daroo Company, containing 44.7% propanol, 21.9% 1-propanol and 0.1% benzalkonium chloride) for 3 minutes
Category
Prevention
3
Description
Intervention group: Betadine Decosept Scrub. Scrub with 10 cc of betadine for 3 minutes and then rub the hands with 3 cc of decosept solution
Category
Prevention
4
Description
Intervention group: Decospet Betadine Scrub. scrub with 10 cc of Decosept for 3 minutes and then rub the hands with 3 cc of betadine solution
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Sharzad Ahmadpanahi
Street address
Kowsar Hospital, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1021
Email
shahrahmad6871@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Deputy of research and technology, Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Daculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aaghods@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aaghods@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aaghods@yahoo.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the data, such as information about the number of colonies in the hand or the like, can be shared
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
Academic researchers and industry professionals
Under which criteria data/document could be used
There is no specific condition
From where data/document is obtainable
Via email of responsible scientific Study
What processes are involved for a request to access data/document
Data will be sent within two weeks after introduction and request