Antibiotic Concentration in Internal Mammary Graft Preparation

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01324804

Enrollment

Registered

2011-03-29

Start date

2010-11-30

Completion date

Unknown

Last updated

2011-03-29

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

Conditions

Coronary Heart Disease, Surgical Wound Infection

Keywords

postoperative wound healing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Austria

Contacts

Primary ContactMartin Andreas, MD, MBA

martin.andreas@meduniwien.ac.at00431404005262

Outcome results