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A Randomized controlled Trial of Tea Tree Oil Body Wash 8% Versus Chlorhexidine Body Wash 0.2% to Prevent Colonization of methicillin-resistant Staphylococcus aureus in Critically Ill children in hospitalized children

Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100119003106N20
Registration date: 2017-12-11, 1396/09/20
Registration timing: retrospective

Last update: 2017-12-11, 1396/09/20
Update count: 0
Registration date
2017-12-11, 1396/09/20
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
by student
Expected recruitment start date
2016-09-30, 1395/07/09
Expected recruitment end date
2017-09-30, 1396/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized controlled Trial of Tea Tree Oil Body Wash 8% Versus Chlorhexidine Body Wash 0.2% to Prevent Colonization of methicillin-resistant Staphylococcus aureus in Critically Ill children in hospitalized children
Public title
Assessment of Tea Tree Oil Body Wash for Eradication of MRSA
Purpose
Treatment
Inclusion/Exclusion criteria
Age
To 12 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 100
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 Islamic Azad University Of Pharmaceutical Sciences Branch
Street address
Iakhchal Avenue، Qolhak، Dotor Shariati Avenue، Tehran
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IAU.PS.REC.1395.4

Health conditions studied

1

Description of health condition studied
topical methicilline-resistant staphylococcus aureus infection
ICD-10 code
U80.1
ICD-10 code description
Bacterial agents resistant to antibiotics

Primary outcomes

1

Description
Colonization of MRSA
Timepoint
before intervention-after 6 day
Method of measurement
bacterial culture of catheter site

Secondary outcomes

1

Description
Skin Sensitivity
Timepoint
before intervention- after 6 days
Method of measurement
bacterial culture of catheter site

Intervention groups

1

Description
intervention group: apply 8% Tea Tree Oil body wash 4 times a day for 6 days// Control group: Chlorhexidine Body Wash 0.2% 4 times a day for 6 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman-e-Hakim hospital
Full name of responsible person
Solmaz Rahbari
Street address
Tehran- Lashgar intersection-makhsoos street
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University
Full name of responsible person
Dr.Seyd Jalaledin Hosseini Ghoncheh
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Iakhchal avenue، Dotor Shariati avenue، Tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences branch, Islamic Azad University
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
islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Dr Mehdi Rajabi
Position
Assistant professor
Other areas of specialty/work
Street address
pharmaceutical sciences branch of ialamic azad university، Iakhchal avenue، Doctor Shariati Avenue، Tehran
City
tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
mehdirj@aol.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Mehdi Rajabi
Position
Ph.D. in Clinical Pharmacy
Other areas of specialty/work
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Iakhchal avenue، Dotor Shariati avenue، Tehran
City
tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Science Branch
Full name of responsible person
Solmaz Rahbari
Position
pharmacy student
Other areas of specialty/work
Street address
pharmaceutical sciences branch of ialamic azad university، Iakhchal avenue، Doctor Shariati Avenue، Tehran
City
tehran
Postal code
Phone
00
Fax
Email
solmaz_r.1991@yahoo.com
Web page address

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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