Clinical trial NCT01324804: Antibiotic Concentration in Internal Mammary Graft Preparation
Official title: Target Tissue Concentration of Standard Antibiotic Treatment in Coronary Artery Bypass Grafting Using Left Internal Mammary Artery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Surgical Wound Infection
Keywords: postoperative wound healing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight
timeFrame: 10 hours
measure: - Difference of tissue concentration of Cefazolin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight
timeFrame: 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: