This prospective randomized clinical trial study was conducted on 141 patients. Patients without history of antibiotic therapy during the last 72 hours before surgery; no severe renal and liver failure and pregnancy; no active infection. All patients didn't consent to use this procedure in the study. We can't use full dose of cefazolin and excise of sign of infection during administering antibiotic. The patients divided into two groups: continuous infusion group and intermittent group. In this study evaluation of infections was based on superficial type of surgical site infection. Duration of follow- up was 4 weeks. Data analyzed by Chi- square test and t-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041917026N1
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Ali Akbar Karimi Bondarabadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1523 9310
Email address
aliakbarkarimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of bolus and continuous Cefazolin injection in off-pump CABG
Public title
Cefazolin injection in off-pump CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients without history of antibiotic therapy during the last 72 hours before surgery; no severe renal and liver failure and pregnancy; no active infection.
Exclusion criteria: all patients didn't consent to use this procedure in the study. we can't use full dose of cefazolin and excise of sign of infection during administering antibiotic.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
141
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
Yazd Cardiovascular Research Center, Afshar Hospital, Shahid Sadoughi University of Medical Sciences
Street address
Shahid Ghandi Blv- Ebne Sina Ave
City
Yazd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
616
Health conditions studied
1
Description of health condition studied
Infection after cardiac surgery
ICD-10 code
B95.6,B95.
ICD-10 code description
Other staphylococcus as the cause of diseases classified to other chapters,Staphylococcus aureus as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Infection
Timepoint
One month
Method of measurement
Clinical evidence and paraclinical lab
Secondary outcomes
empty
Intervention groups
1
Description
In Bolus group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 1g of Cefazolin were administered at 3, 11 and 19 hours after starting dose respectively .therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections.
Category
Prevention
2
Description
In continuous group, for patients undergoing Off- Pump Coronary Artery Bypass Graft surgery. Patients in this group received 2g of Cefazolin as a starting dose, 30 minutes before incision. Then 3g of Cefazolin continuously infused during 24 hours. Therefore, overall 5gr cefazolin administered intravenously .after surgery,we survey clinical examinations and paraclinical tests .then we follow –up patients during one month about post-operative infections.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Afshar hospital
Full name of responsible person
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid sadoughi university of medical science, Yazd
Full name of responsible person
Fatemeh Ezoddini Ardakani
Street address
2th floor- the building number one of Shahid Sadoughi Uuniversity of Medical Sciences- Bahonar sq, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid sadoughi university of medical science, Yazd
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
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Seyed Khalil Forouzannia
Position
Professor of cardiovascular surgery
Other areas of specialty/work
Street address
Afshar hospital-Jomhori Blvd,yazd
City
Yazd
Postal code
Phone
+98 35 1523 1421
Fax
Email
drforouzan_nia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Seyed Khalil Forouzannia
Position
Professor
Other areas of specialty/work
Street address
Afshar hospital-Jomhori Blvd,yazd
City
Yazd
Postal code
Phone
+98 35 1523 1421
Fax
Email
drforouzan_nia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Ali Akbar Karimi Bondarabadi
Position
Medical student
Other areas of specialty/work
Street address
Ebne Sina blvd-Shahid ghandi Blv-yazd
City
Yazd
Postal code
Phone
+98 35 1523 1421
Fax
Email
aliakbarkarimi90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)