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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.
Sponsored by: Far Eastern Memorial Hospital
Information provided by: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00711685
  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

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease
Drug Information available for: Vancomycin Vancomycin hydrochloride Methicillin Methicillin sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Topical Vancomycin in Prevention of Methicillin-Resistant Staphylococcal Related Mediastinitis in Patients Receiving Coronary Artery Bypass Graft

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)
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  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

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

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Thoracic Diseases
Vascular Diseases
Ischemia
Arteriosclerosis
Mediastinitis
Coronary Disease
Methicillin
Respiratory Tract Diseases
Vancomycin
Coronary Artery Disease
Mediastinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009