Antibiotic Concentration in Internal Mammary Graft Preparation

Study Overview
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Brief Summary
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The negative effect of internal mammary harvesting on sternal perfusion is well known, especially in diabetic subjects. Microdialysis previously showed increased lactate tissue concentration after mammary artery preparation. Although high antibiotic concentration is of utmost importance in this region, no study previously measured the effect of internal mammary artery harvesting on target tissue antibiotic concentration. Study hypothesis: Internal mammary artery harvesting imposes an additional risk for deep sternal wound infection by impairing antibiotic tissue penetration. This effect is mediated by altered perfusion patterns and may be seen in cephalosporin and/or Teicoplanin treatment. Study objective: To evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of Cefazolin and Teicoplanin during cardiac surgery Design: This study is designed as an observational pharmacokinetic trial. Patients are their own controls by measuring antibiotic concentration in different subcutaneous tissues. Study population: Patients referred for coronary artery bypass grafting to the Department of Cardiothoracic Surgery with planned unilateral left internal mammary artery preparation and a high risk profile for deep sternal wound infections will be asked to participate in this trial.

Official Title
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Target Tissue Concentration of Standard Antibiotic Treatment in Coronary Artery Bypass Grafting Using Left Internal Mammary Artery

Conditions
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Coronary Heart Disease, Surgical Wound Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Planned coronary artery bypass grafting with unilateral internal mammary artery bypass Planned used of cardiopulmonary bypass Exclusion Criteria: Inability to give informed consent Know allergy to cephalosporins, penicillin or Teicoplanin Re-operation Additional planned valve surgery Dialysis BMI > 30 Long standing diabetes mellitus (> 7 years) Ejection fraction below 20% measured with transthoracic echocardiography Chronic severe renal insufficiency Childbearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CABG - subjects<br>only one group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight | measurement with microdialysis | 10 hours | 
| - Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight | measurement with microdialysis | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative wound healing