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

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ClinicalTrials.gov Identifier: NCT00711685
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : July 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Disease Procedure: coronary artery bypass grafting via midline sternotomy

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Topical Vancomycin in Prevention of Methicillin-Resistant Staphylococcal Related Mediastinitis in Patients Receiving Coronary Artery Bypass Graft
Study Start Date : January 2007
Primary Completion Date : December 2007

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Arms and Interventions


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00711685     History of Changes
Other Study ID Numbers: 95033
FEMH-95-C-040
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

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
Vancomycin
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents