CClinicalTrials.gg
Status unknownNCT01324804Updated Mar 29, 2011

Antibiotic Concentration in Internal Mammary Graft Preparation

An observational study in Coronary Heart Disease and Surgical Wound Infection, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-29.

Sponsored by Medical University of Vienna · Observational

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Heart Disease
  • Surgical Wound Infection

Keywords

  • postoperative wound healing
03

In context

Wound Infection

382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.

This study's planned enrollment of 12 is below the median of 217 across 66 observational studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

  • Written informed consent
  • Planned coronary artery bypass grafting with unilateral internal mammary artery bypass
  • Planned used of cardiopulmonary bypass

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (estimated)

Groups and cohorts

  • CABG - subjects

    only one group

06

What researchers measure

Primary outcomes

  1. - 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

    Time frame: 10 hours

  2. - 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

    Time frame: 10 hours

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01324804
Lead sponsor
Medical University of Vienna
First posted
Mar 29, 2011
Start date
Nov 2010
Last update
Mar 29, 2011

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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