Comparison of the effect of three antiseptic solutions: Betadine 7.5%, combination of alcohol70%–Betadine7.5% and Alprosept on reducing the bacterial agents of hands before surgery
Objective: To determine the effect of three antiseptic solutions: Betadine 7.5%, combination of alcohol70%–Betadine7.5% and Alprosept on reducing the bacterial agents of hands before surgery
Design: A randomized control trial without blinding
Study population: Surgical staff of operating room department
Setting and conduct: With block random allocation, samples will be included in three group: case 1 (Alprosept), case 2 (combination of alcohol70%–Betadine7.5%) and control (Betadine 7.5%). After washing and drying their hands with soap, sample will be provided on a medium containing normal saline by rubbing a sterile swab to first to third fingers and palms to determine the basic criteria. Then, each of the samples, separately, three times with an interval of 24 hours, each time accidentally will used from one of the solutions. After the scrub and dry hands before putting on gloves, sample will be provided and after cultivation, the number and types of colonies will be counted.
Main inclusion criteria: At least one years’ experience in the operating room in scrub role; avoiding the use of antibiotics in ten days before
Main exclusion criteria: Allergy to used solutions
Sample size: 30 person
Interventions: Hand scrub with a solution Alprosept for group case 1, combination of alcohol 70%–Betadine7.5% for group case 2 and Betadine 7.5% for control group.
Intervention time: Before surgery
Outcomes of study: The number and types of colonies
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603143064N4
Registration date:2016-07-11, 1395/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research - Shahroud University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of three antiseptic solutions: Betadine 7.5%, combination of alcohol70%–Betadine7.5% and Alprosept on reducing the bacterial agents of hands before surgery
Public title
Comparison of the effect of three antiseptic solutions: Betadine 7.5%, combination of alcohol70%–Betadine7.5% and Alprosept on reducing the bacterial agents of hands before surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Main inclusion criteria: At least one years’ experience in the operating room in scrub role; avoiding the use of antibiotics in ten days before
Main exclusion criteria: Allergy to used solutions
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahroud University of Medical Sciences
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SHMU.REC.1394.141
Health conditions studied
1
Description of health condition studied
Disinfectant
ICD-10 code
T49.9
ICD-10 code description
Topical agent, unspecified
Primary outcomes
1
Description
Bacterial agents of hand
Timepoint
Before surgery
Method of measurement
Blood agar and EMB culture
Secondary outcomes
empty
Intervention groups
1
Description
Hand scrub with a solution Alprosept for group case 1
Category
Other
2
Description
Hand scrub with combination of alcohol 70%–Betadine7.5% for group case 2
Category
Other
3
Description
Hand scrub with Betadine 7.5% for control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Hospital
Full name of responsible person
Dr. Hossein Bagheri
Street address
End of touhidi 28 meters, Imam street
City
Shahroud
2
Recruitment center
Name of recruitment center
Fatemiyeh Hospital of Shahroud
Full name of responsible person
Dr. Hossein Bagheri
Street address
22 Bahman street, Fatemiyeh Hospital
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research - Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research - Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Hafte-Tir Square, shahroud University of Medical Sciences anymore
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
bagheri@shmu.ac.ir
Web page address
http://pr.shmu.ac.ir/fa/nurs/7813m911o
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
bagheri@shmu.ac.ir
Web page address
http://pr.shmu.ac.ir/fa/nurs/7813m911o
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
bagheri@shmu.ac.ir
Web page address
http://pr.shmu.ac.ir/fa/nurs/7813m911o
Sharing plan
Deidentified Individual Participant Data Set (IPD)