Comparison of effect of povidone iodine 7.5% versus sequential povidone iodine and decosept hand scrub on incidence of local symptoms of infection at the site of cardiac implantable electronic device
This clinical trial comparison of effect pf povidone iodine 7.5%versus sequential povidone iodine and decosept hand scrub on incidence of local symptom of infection at the site of cardiac implantable electronic device .220 patient randomised divided two groups
Type of trial: Random sampling block
the way of information search: questionary and checklist
Inclusion criteria:" no given imonosupressive drug"- :" no given antibiotic":-" no problem in imono system" : - "no problem extrimity " : - "candid cied"
Exclusion criteri: " lack of patient satisfaction" :- " fever -INR>2"
patienst randomised divided in two groups:
Interventional group1:after general cleansing hand scrub with betadine 7.5% for 3 minutes, using 5 ml of decosept then were dried with strile towels
Control group: after general cleansing hand scrub with betadine 7.5% for 3 minutes, using then were dried with strile towels. in presence local symptom of infection at the site of cardiac implantable electronic device after 24 houre and then 3 mounth were reported.
General information
Acronym
CIED
IRCT registration information
IRCT registration number:IRCT2015051822301N1
Registration date:2016-03-02, 1394/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Khadige Rashedimanesh
Name of organization / entity
Shiraz university of medicalsciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 0746
Email address
stud2295296137@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
goverment
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of povidone iodine 7.5% versus sequential povidone iodine and decosept hand scrub on incidence of local symptoms of infection at the site of cardiac implantable electronic device
Public title
effect of povidone iodine 7.5% sequential decosept hand scrub on decrease of incidence of local symptoms of infection at the site of cardiac implantable device electronic device
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:" no given imonosupressive drug"- :" no given antibiotic":-" no problem in imono system" : - "no problem extrimity " : - "candid cied"
Exclusion criteri: " lack of patient satisfaction" :- " fever -INR>2"
Age
From 3 days old to 93 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
220
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
incidence of cied
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz Univercity of Medical Sciences
Street address
Zand street Shiraz University of Medical Sciences
City
Shiraz
Postal code
71345-1978
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
IR.SUMS.REC.CT-93-7433
Health conditions studied
1
Description of health condition studied
Heart failer
ICD-10 code
150.1
ICD-10 code description
نارسایی قلبی
Primary outcomes
1
Description
Incidence of infection
Timepoint
24 houre and least 3month after of intervention
Method of measurement
Checklist and clinical presentation
Secondary outcomes
1
Description
Erythema -swelling -hematom-fever-draiage
Timepoint
1day and 3moth after intervention
Method of measurement
Checklist and presentation
Intervention groups
1
Description
Intervention Group:
110 patient that surgical team hand scrub with povidone iodine 7.5 percent then to dried with stril towel then seqentional used decosept gel.
Category
Prevention
2
Description
control:rootin scrub 110 patient that surgical team hand scrub with povidone iodine 7.5 percent only
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dr nikoo
Street address
Zand street faghihi hospital angiography ward
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reasearch, Shiraz University of Medical Sciences
Full name of responsible person
Dr poostfroosh
Street address
Zand stree, Shiraz University of Medical Science
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reasearch, Shiraz 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
Shiraz University of Nursing of Sciences
Full name of responsible person
Zahra molazem
Position
Phd nursing
Other areas of specialty/work
Street address
Square namazi Shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 3230 5099
Fax
+98 71 3230 5099
Email
Molazemzah@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical of Sciences
Full name of responsible person
Zahra molazem
Position
Phd nursing
Other areas of specialty/work
Street address
Zand street
City
Shiraz
Postal code
Iran
Phone
+98 71 3647 4254
Fax
no
Email
Molazemzah@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Faghihi Hospital
Full name of responsible person
Rashdimanesh khadijeh
Position
Master
Other areas of specialty/work
Street address
Zand stree,Faghihi Hospital, Shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 3230 5099
Fax
Email
stud2295296137@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)