Protocol summary

Summary
The present research is random study without control by placebo. The statistical population includes all patients admitted to the intensive care unit of Khatam Hospital, affiliated with Zahedan University of Medical Sciences, in 2017. In these patients, patients with multiple trauma, aged 20-60 who were hospitalized in the ICU for at least 48 hours were selected as the sample. The exclusion criteria were affliction with infectious diseases or diabetes, pregnancy (for women), and discharge or transfer to another ward before 48 hours. Sample size: Based on previous studies and considering a statistical power of 90% at a confidence level of 95%, the sample size for each of the experimental groups was determined to be 35. To increase the level of confidence and compensate for possible loss of samples, 40 subjects were assigned to each group. Intervention: In the control group, sampling will be done using a sterile swab from areas of the armpits, groin, and neck folds on arrival at the hospital and 48 hours after hospitalization without any intervention. Sampling of the same body areas in the intervention group will be conducted with the same method on arrival at the hospital and 48 hours after hospitalization and daily 2% chlorhexidine bath. For bathing, the entire body of patients, except their face, should be treated with a pad containing 2% chlorhexidine solution. Samples will be cultured by the fellow researcher and, 24 hours after incubation, the number of colonies will be counted. Then, samples will be cultured again for determining the type of microorganisms and conduction of antibiotic sensitivity test. Finally, the results of two groups will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030932293N1
Registration date: 2017-03-21, 1396/01/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Hamed Sarani
Name of organization / entity
Zahedan University Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
sarani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of daily 2% chlorhexidine bathing, on colonization of the skin of patients admitted to Khatam's hospital ICU of the Zahedan University of Medical Sciences in 2017.
Public title
Chlorhexidine effect on skin colonization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: In these patients, patients with multiple trauma, aged 20-60 who were hospitalized in the ICU for at least 48 hours were selected as the sample. Exclusion criteria: The exclusion criteria were affliction with infectious diseases or diabetes, pregnancy (for women), and discharge or transfer to another ward before 48 hours.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Zahedan University of Medical Sciences
Street address
Zahedan University Medical Sciences, Hesabi Sq, University Street, Zahedan
City
Zahedan
Postal code
9816913396
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.ZAUMS.REC.1395. 247

Health conditions studied

1

Description of health condition studied
nosocomial infection
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
colonies number
Timepoint
First and third days of hospitalization
Method of measurement
culture

2

Description
type of micro-organisms
Timepoint
First and third days of hospitalization
Method of measurement
culture

3

Description
Drug resistance
Timepoint
First and third days of hospitalization
Method of measurement
Antibiotic SensitivityTest

Secondary outcomes

1

Description
duration of hospitalization
Timepoint
-
Method of measurement
days

Intervention groups

1

Description
In the control group, sampling will be done using a sterile swab from areas of the armpits, groin, and neck folds on arrival at the hospital and 48 hours after hospitalization without any intervention.
Category
N/A

2

Description
Sampling of the same body areas in the intervention group will be conducted with the same method on arrival at the hospital and 48 hours after hospitalization and daily 2% chlorhexidine bath. For bathing, the entire body of patients, except their face, should be treated with a pad containing 2% chlorhexidine solution. Samples will be cultured by the fellow researcher and, 24 hours after incubation, the number of colonies will be counted. Then, samples will be cultured again for determining the type of microorganisms and conduction of antibiotic sensitivity test. Finally, the results of two groups will be compared with each other.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatm-al-anbia hospital affiliated with the Zahedan University of Medical Sciences
Full name of responsible person
Hamed sarani
Street address
Nursing and Midwifery Department, Zahedan University of Medical Sciences, Dr Hesabi Sq, University Street, Zahedan, Iran
City
Zhedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed sarani
Street address
Zahedan University of Medical Sciences, Dr Hesabi square, University Street
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hamed sarani
Position
Masters
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Zahedan Medical Sciences University,Hesabi Sq, university street, Zahedan,Iran.
City
Zahedan
Postal code
9816653948
Phone
+54 33442481
Fax
+54 33442481
Email
sarani@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamed sarani
Position
Masters
Other areas of specialty/work
Street address
Nursing and Midwifery Department, Zahedan Medical Sciences University,Hesabi Sq, university street, Zahedan,Iran.
City
Zahedan
Postal code
9816653948
Phone
+54 33442481
Fax
+54 33442481
Email
sarani@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Soleiman bidar
Position
Student
Other areas of specialty/work
Street address
No. 16, alley seidyan, West Taleghani street, Mahabad, West Azarbaijan, Iran
City
Mahabad
Postal code
Phone
+98 44 4235 1647
Fax
Email
s.bidar16@yahoo.coms.bidar62@gmail.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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