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Comparison of two prophylactic antibiotic regimens (cefazolin and cefazolin+gentamicin) on surgical wound infection of CABG patients

Comparison of two prophylactic antibiotic regimens (cefazolin and cefazolin+gentamicin) on surgical wound infection of CABG patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201201114365N10
Enrollment
400
Registered
2012-02-01
Start date
2011-02-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylactic antibiotic. Prophylactic antibiotic therapy

Interventions

Intervention 1: 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. Intervention 2: In the second group the
Treatment - Drugs
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 eve
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.

Sponsors

Vice chancellor for research of Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Surgical wound infection. Timepoint: 3, 7, 21 and 30 days after cardiac surgery. Method of measurement: observation - culture.

Secondary

MeasureTime frame
Creatinine. Timepoint: 2 -4 days after surgery. Method of measurement: Laboratory kit - mg/dl.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Gholipour Baradari MD

Mazandaran University Of Medical Sciences

gholipourafshin@mazums.ac.ir; gholipourafshin@yahoo.com+98 15 1326 1245

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026