NCT00711685

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
Last Updated

July 9, 2008

Status Verified

July 1, 2008

Enrollment Period

11 months

First QC Date

July 7, 2008

Last Update Submit

July 8, 2008

Conditions

Coronary Artery Disease

Keywords

Topical vancomycinmediastinitiscoronaryarterybypassgraftPatients

Interventions

coronary artery bypass grafting via midline sternotomyPROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary artery disease underwent aoronary artery bypass grafting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMediastinitis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Study Officials

  • Kuan-Ming Chiu, M.D.

    Far Eastern Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 9, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Last Updated

July 9, 2008

Record last verified: 2008-07

Locations

TW(1)