The aim of this randomized clinical trial is to Comparison of two prophylactic antibiotic regimens (cefazolin and cefazolin+gentamicin) on surgical wound infection of CABG patients in Mazandaran Heart Center.
Inclusion criteria are informed written consent; Age between 40 and 75 years; Elective CABG surgery; Use of the cardiopulmonary pump during surgery.
Exclusion criteria are history of infectious disease and use of antibiotic during previous week; Renal failure (baseline serum creatinine > 2mg/dl); systemic disease and drugs causing immunosuppression; together with other cardiac surgery (valvular surgery); Reoperation; Ejection fraction < 35%; history of sensitivity to cephalosporin or Gentamicin.
A total of 400 patients, meeting eligibility criteria, are randomly allocated into two equal groups.
In the first group the prophylactic regimen consists of Cefazolin 2 g IV before sternal incision followed by 1 g IV every 6 hours for 72 hours.
In the second group the prophylactic regimen consists of Cefazolin 2 g IV plus Gentamicin 1.5mg/kg IV before sternal incision followed by Cefazolin 1 g IV every 6 hours plus Gentamicin 1.5mg/kg IV every 8 hours for 72 hours.
Patients are observed by cardiac surgeon for signs of surgical wound infection at 3, 7, 21 and 30 days after cardiac surgery and results are recorded in the data collection form.
General information
Acronym
CABG: Coronary Artery Bypass Graft
IRCT registration information
IRCT registration number:IRCT201201114365N10
Registration date:2012-02-01, 1390/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two prophylactic antibiotic regimens (cefazolin and cefazolin+gentamicin) on surgical wound infection of CABG patients
Public title
Comparison of two prophylactic antibiotic regimens (cefazolin and cefazolin+gentamicin) on surgical wound infection of CABG patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are informed written consent; Age between 40 and 75 years; Elective CABG surgery; Use of the cardiopulmonary pump during surgery.
Exclusion criteria are history of infectious disease and use of antibiotic during previous week; Renal failure (baseline serum creatinine > 2mg/dl); systemic disease and drugs causing immunosuppression; together with other cardiac surgery (valvular surgery); Reoperation; Ejection fraction < 35%; history of sensitivity to cephalosporin or Gentamicin.
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
46175866
Approval date
2011-02-16, 1389/11/27
Ethics committee reference number
90-137
Health conditions studied
1
Description of health condition studied
Prophylactic antibiotic
ICD-10 code
Z29.2
ICD-10 code description
Prophylactic antibiotic therapy
Primary outcomes
1
Description
surgical wound infection
Timepoint
3, 7, 21 and 30 days after cardiac surgery
Method of measurement
observation - culture
Secondary outcomes
1
Description
Creatinine
Timepoint
2 -4 days after surgery
Method of measurement
Laboratory kit - mg/dl
Intervention groups
1
Description
In the first group the prophylactic regimen consists of Cefazolin 2 g IV before sternal incision followed by 1 g IV every 6 hours for 72 hours.
Category
Treatment - Drugs
2
Description
In the second group the prophylactic regimen consists of Cefazolin 2 g IV plus Gentamicin 1.5mg/kg IV before sternal incision followed by Cefazolin 1 g IV every 6 hours plus Gentamicin 1.5mg/kg IV every 8 hours for 72 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart center
Full name of responsible person
Afshin Gholipour Baradari
Street address
Mazandaran Heart center, Artesh Blvd
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran university of medical sciences, Moallem Square
City
Sari
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 Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square