Central venous (CV) catheters play an essential role in the management of critically ill patients in the Intensive Care Unit (ICU).CV lines are, however, allied to catheter-associated blood stream infections.Bacterial colonization of CV lines is deemed the main cause of catheter-associated infection. The purpose of our study is to compare bacterial colony counts in the catheter site before CV line insertion in two groups of post-cardiac surgery patients: a group receiving Sanosil (an antiseptic agent composed of H2O2 and silver) and a control group.
The study is design as an interventional prospective double-blinded clinical trial recruited the patients in three post-cardiac surgery ICU's of a heart center. 250 patients will be randomized to be treated with sanosil plus their rutine infection control prophyilactic mrasures or without it. The participants will divided into interventional and control groups. Sanosil spray will be added to the routine preparation procedure (Chlorhexidine bath one day before and scrub with Povidone-Iodine just before the CV line insertion). After the removal of the CV lines atanaverage of three days, the catheters tips will be sent for culture and evaluation of colony counts.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009014672N1
Registration date:2013-05-25, 1392/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Fardin Yousefshahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
yousefshahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Silver based antiseptics application for control of Central Venous catheters colonization in cardiac surgery
Public title
Efficacy of Silver based antiseptics application for decrease of Central Venous catheter infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for open-heart surgery in Tehran Heart Center; signing the consent for participation in the study; without any evidence of infection at the time of admission.
Exclusion criteria: infection on arrival or occurrence of infection in first 48 hours after arrival; not being admitted to the post ICU for any reason.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
PO Box 1417614411, Floor 8, Tehran University of Medical Sciences, Qods Street, Tehran, Iran.
City
Tehran
Postal code
Approval date
2010-12-12, 1389/09/21
Ethics committee reference number
130/1122/د/89
Health conditions studied
1
Description of health condition studied
catheter related infection profilaxis
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
colonization of bacteria in Central Venous Catheter
Timepoint
after catheter removal
Method of measurement
positive or negative cultures
2
Description
the type of isolated microorganism from the CVline
Timepoint
after catheter removal
Method of measurement
the type of microorganism
Secondary outcomes
1
Description
leuckocytosis
Timepoint
admission period
Method of measurement
wight blood cell count more than normal value
2
Description
Ferver
Timepoint
admission period
Method of measurement
body temperature more than 37.8 centigrade
3
Description
sepsis symptoms and signs
Timepoint
admission period
Method of measurement
evaluation of clinical and para-clinical factores
Intervention groups
1
Description
Sanosil spraying on the insertion point by an standard spray, 3 puffs, half an hour before surgery, in preparation room
Category
Treatment - Drugs
2
Description
distilled water spraying on the insertion point by an standard spray, 3 puffs, half an hour before surgery, in preparation room
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Fardin Yousefshahi
Street address
Tehran Heart Center, Al-ahmad & Kargar Cross
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center, Infection Control Section
Full name of responsible person
Dr. Mohamadali Broomand
Street address
Infection Control section, Tehran Heart Center, Al-ahmad & Kargar Cross, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart Center, Infection Control Section
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
Tehran University of Medical Sciences
Full name of responsible person
Fardin Yousefshahi MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran PO Box: 1411713138, Tehran Heart Center, Al-ahmad & Kargar Cross, Tehran, Iran.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9633
Fax
Email
yousefshahi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fardin Yousefshahi MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
PO Box: 1411713138, Tehran Heart Center, Al-ahmad & Kargar Cross, Tehran, Iran.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9633
Fax
Email
yousefshahi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fradin Yousefshahi MD
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
PO Box: 1411713138, Tehran Heart Center, Al-ahmad & Kargar Cross, Tehran, Iran.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
yousefshahi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)