Protocol summary

Summary
The aim of this study is comparison the effect of water and soap and disinfectant solution (Hndrab) on hands` infection of nurses at intensive care unit of 5azar tertiary hospital. Inclusion Criteria: Having work history (at least 1 year) at intensive care unit; Filing the informed consent form. Exclusion Criteria: No tendency to participate in the study after entering to the study; Reporting of skin problems by nurses. In this single blind crossover clinical trial study, 60 nurses working at intensive care unit will be assigned to two groups of 30 nurses by simple random allocation. In intervention group, hands will be washed with disinfectant solution (Hndrab) and sampling of personnel` hands will be done 2 times; 3 hours after initiating of shift and before washing hands with Hndrab and 5 minutes after washing hands with Hndrab. In control group, hands will be washed with water and soap and sampling will be done 2 times; 3 hours after initiating shift and before washing hands with water and soap and 5 minutes after washing hands with water and soap. Samples will be incubated for 24 hours. They will be cultured on Blood Agar and EMB and will be incubated for 24 hours. Then, they will be evaluated for growth, lack of growth and number of colonies of bacteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050422080N1
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Soheila Samadzadeh
Name of organization / entity
Golestan University of Medical Sciences, Gorgan, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 6270
Email address
samadzadeh_soheila@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of research & technology, Golestan University of Medical Sciences, Gorgan, Iran.
Expected recruitment start date
2015-04-06, 1394/01/17
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Comparison the Effect of Water and Soap and Disinfectant Solution (Hndrab) on Hands` infection of Nurses at Intensive Care Unit
Public title
Effect of Water and Soap and Disinfectant Solution (Hndrab) on Hands` infection of Nurses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Having Work History (at least 1 year) at Intensive Care; Filing the Informed Consent Form. Exclusion Criteria: No Tendency to Participate in the Study after Entering to the Study; Reporting of Skin Problems by Nurses.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Not 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
Golestan University of Medical Sciences, Gorgan, Iran.
Street address
Educational Campus of Golestan University of Medical Sciences,Shastkola Road, Gorgan, Iran.
City
Gorgan
Postal code
iran
Approval date
2015-03-15, 1393/12/24
Ethics committee reference number
3107869312244

Health conditions studied

empty

Primary outcomes

1

Description
Hand Infection
Timepoint
Before intervention, 5 minutes after intervention
Method of measurement
Culturing of samples on culture environment and evaluation of incubated culture environment for growth, lack of growth and number of colonies of bacteria.

Secondary outcomes

1

Description
Bacteria
Timepoint
Before intervention, 5 minutes after intervention
Method of measurement
Differential tests and Gram stain

Intervention groups

1

Description
Intervention group: Washing hands with disinfectant solution (Hndrab), one time during a shift, at least 3 hours after shift initiation.
Category
Prevention

2

Description
Control group: Washing hands with water and soap, one time during a shift, at least 3 hours after shift initiation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinical Research Development Unit (CRDU), 5 Azar Hospital, Golestan University of Medical Sciences,
Full name of responsible person
Soheila Samadzadeh
Street address
5 Azar Hospital, Gorgan, Iran.
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of research & technology, Golestan University of Medical Sciences, Gorgan, Iran.
Full name of responsible person
Dr. Masoud Khoshnia
Street address
Educational Campus of Golestan University of Medical Sciences,Shastkola Road, Gorgan, Iran.
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of research & technology, Golestan University of Medical Sciences, Gorgan, Iran.
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
Golestan University of Medical Sciences, Gorgan, Iran.
Full name of responsible person
Soheila Samadzadeh
Position
Software Engineering
Other areas of specialty/work
Street address
5 Azar Hospital, Gorgan, Iran.
City
Gorgan
Postal code
Phone
+98 17 3232 6270
Fax
Email
samadzadeh_soheila@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences, Gorgan, Iran.
Full name of responsible person
Dr. Rahmatollah Sharififar
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
5 Azar Hospital, Gorgan, Iran.
City
Gorgan
Postal code
Iran
Phone
+98 17 3233 0230
Fax
Email
drsharififar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Research and Technology, Golestan University of Medical Sciences, Gorgan, Iran.
Full name of responsible person
Soheila Samadzadeh
Position
Software Engineering
Other areas of specialty/work
Street address
5 Azar hospital
City
Gorgan
Postal code
Iran
Phone
+98 17 3232 6270
Fax
Email
samadzadeh_soheila@yahoo.com
Web page address
www.goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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