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Antibiotic Concentration in Internal Mammary Graft Preparation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Medical University of Vienna.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01324804
First Posted: March 29, 2011
Last Update Posted: March 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

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.


Condition
Coronary Heart Disease Surgical Wound Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Target Tissue Concentration of Standard Antibiotic Treatment in Coronary Artery Bypass Grafting Using Left Internal Mammary Artery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • - Difference of tissue concentration of Teicoplanin between left and right pre-sternal subcutaneous tissue and between the subcutaneous tissue at the tight [ Time Frame: 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 [ Time Frame: 10 hours ]
    measurement with microdialysis


Estimated Enrollment: 12
Study Start Date: November 2010
Groups/Cohorts
CABG - subjects
only one group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324804


Contacts
Contact: Martin Andreas, MD, MBA 00431404005262 martin.andreas@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Martin Andreas, MD, MBA    00431404005262    martin.andreas@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
  More Information

Responsible Party: Medical University of Vienna, Department of Cardiothoracic- and Vascular Anaesthesia & Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT01324804     History of Changes
Other Study ID Numbers: Version 1.1 - 19.11.2009
First Submitted: March 28, 2011
First Posted: March 29, 2011
Last Update Posted: March 29, 2011
Last Verified: December 2009

Keywords provided by Medical University of Vienna:
postoperative wound healing

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Wound Infection
Surgical Wound Infection
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents