Protocol summary

Summary
Aims: This study aimed to comparison the effects of Povidone Iodine and Chlorhexidine as detergent on bacterial colony count of skin hand under surgery in operation room . Materials and methods: This study is a clinical trial conducted on 64 patients hospitalized for hand surgery. The patients were selected by simple sampling method and were randomly assigned to two groups (study and control), 32 person in each group. The prep and drape was done on their hands. Including criteria were all men and women under hand surgery, and excluding criteria were wound and dermatitis on hand skin. Patients’ data was collected, including demographic data and colony count. Independent variable was detergents, and primary outcome was colony counts.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031121431N1
Registration date: 2015-12-12, 1394/09/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Mahtab Aghakarimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 0076
Email address
mahtabaghakarimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Isfahan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of two methods preparation with Chlorhexidine and Povidone Iodine on colony count on hand surgery
Public title
Comparison effects of two methods preparation with Chlorhexidine and Povidone Iodine on colony count
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria were all men and women under hand surgery, excluding criteria were wound and dermatitis on hand skin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Chart number randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib Street, Isfahan.
City
Isfahan
Postal code
81746-73461
Approval date
2013-07-28, 1392/05/06
Ethics committee reference number
292068

Health conditions studied

1

Description of health condition studied
hand surjery
ICD-10 code
I
ICD-10 code description
B90-B94

Primary outcomes

1

Description
The bacterial colony count
Timepoint
Before and after perp, and end of surgery
Method of measurement
counting of bacterial coloni

Secondary outcomes

empty

Intervention groups

1

Description
prep of hand before surgery with Povidone Iodine and Chlorhexidine Name:cholorhexidin4%, material effect: cholorhexidin gluconate 2%and isopropyl70%
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Medical and Educational Center
Full name of responsible person
Mahtab Aghakarimi
Street address
Kashani Street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Neamatbakhsh
Street address
Azadi Square, Hezar-Jerib street, Isfahan University of Medical Sciences,
City
Isfahan
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 of Isfahan 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
Isfahan University of Medical Scienes
Full name of responsible person
Mahtab Aghakarimi
Position
Supervaisor
Other areas of specialty/work
Street address
Kashani Street, Kashani Hospital
City
Isfahan
Postal code
Phone
+98 31 3650 0076
Fax
Email
mahtabaghakarimi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Scienes
Full name of responsible person
Yousefi Hojatollah
Position
PhD
Other areas of specialty/work
Street address
Azadi Square, Hezar Jerib Ave., Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
73461-81746
Phone
+98 31 3792 7543
Fax
Email
yousefi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahtab Aghakarimi
Position
Nursing/Supervaisor
Other areas of specialty/work
Street address
Kashani Medical Educational Center
City
Isfahan
Postal code
8179957394
Phone
+98 31 3650 0076
Fax
Email
mahtabaghakarimi@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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