Target tissue concentration of standard antibiotic treatment in coronary artery bypass grafting using left internal mammary artery - Antibiotic concentration in internal mammary graft preparation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016532-12-AT

Enrollment

Unknown

Registered

2009-12-09

Start date

2009-12-28

Completion date

Unknown

Last updated

2016-11-21

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

Conditions

antibiotic target tissue protection during cardiac surgery with the use of an internal mammary artery graft to prevent deep sternal wound infection MedDRA version: 12.0 Level: LLT Classification code 10011078 Term: Coronary artery disease MedDRA version: 12.0 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy

Interventions

Trade Name: CEFAZOLIN "Sandoz" 2 g - Trockenstechampulle Product Name: Cefazolin Sandoz 2 g-Trockenstechampulle Product Code: 1–20223 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent - Planned coronary artery bypass grafting with unilateral internal mammary artery bypass - Planned used of cardiopulmonary bypass Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Inability to give informed consent - Know allergy to cephalosporins, penicillin or Teicoplanin - Re-operation - Additional planned valve surgery - Dialysis - Chronic severe renal insufficiency - Childbearing potential

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery;Secondary Objective: To evaluate the difference between subcutaneous persternal antibiotic concentration to concentration on the thigh;Primary end point(s): - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight - Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight - Pharmacokinetics in dual antibiotic prophylaxis - Comparison of target tissue concentration to plasma concentration at different time points prior to, during and after cardiopulmonary bypass	—

Measure

Time frame

Main Objective: To evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery;Secondary Objective: To evaluate the difference between subcutaneous persternal antibiotic concentration to concentration on the thigh;Primary end point(s): - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight - Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight - Pharmacokinetics in dual antibiotic prophylaxis - Comparison of target tissue concentration to plasma concentration at different time points prior to, during and after cardiopulmonary bypass

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Countries

Austria

Outcome results

None listed

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