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Topical Vancomycin in Prevention of Methicillin-Resistant Staphylococcal Related Mediastinitis in Patients Receiving Coronary Artery Bypass Graft

This study has been completed.
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00711685
First received: July 7, 2008
Last updated: July 8, 2008
Last verified: July 2008
History of Changes
  Purpose

Sternal or mediastinal infections after heart operation occurs infrequently but carries a high cost in money, morbidity, and mortality. At our hospital, Staphylococcus species cause most of these infections and is uniformly sensitive to vancomycin. However, the relative low concentration of vancomycin in sternal bone was noted given intravenously. Topical vancomycin was therefore considered to apply on the cut edege of sternal bone before closure in patients receiving coronary artery bypass graft to evaluate the effect on reducing the infection rate of staphylococcus related mediastinitis (6). In addition, we try to observe that prophylactic use of topical vancomycin will increase the risk for acquiring resistant pathogen such as VISA (vancomycin-intermediate S. aureus), VRSA (Vancomycin-resistant S. aureus), VRE (vancomycin-resistant enterococcus)


Condition Intervention
Coronary Artery Disease
 Procedure: coronary artery bypass grafting via midline sternotomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Topical Vancomycin in Prevention of Methicillin-Resistant Staphylococcal Related Mediastinitis in Patients Receiving Coronary Artery Bypass Graft

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 50
Study Start Date: January 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with coronary artery disease underwent aoronary artery bypass grafting

Exclusion Criteria:

  • Patients who ever received vancomycin or teicoplanin or linezolids within one week will be excluded. Other exclusion criteria are patients in pregnant, allergic to vancomycin, and hesitate to this study plan.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711685

Locations
Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Director: Kuan-Ming Chiu, M.D. Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00711685     History of Changes
Other Study ID Numbers: 95033, FEMH-95-C-040
Study First Received: July 7, 2008
Last Updated: July 8, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
Topical vancomycin
mediastinitis
coronary
artery
 bypass
graft
Patients

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Mediastinitis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Methicillin
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013