Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
- Registration Number
- NCT01080963
- Lead Sponsor
- Hannover Medical School
- Brief Summary
The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
- age between 18-80
- written informed consent (IC)
Exclusion Criteria
- pregnant and lactating women
- patients operated for a transplantation
- patients with a increased myopathy risk
- patients with a creatinine clearance < 30ml/min; patients on hemodialysis
- patients after a previous sternotomy
- treatment with any antibiotics 14 days prior study start
- treatment with Daptomycin or Cefuroxime within 3 month prior study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daptomycin Daptomycin - Cefuroxime Cefuroxime -
- Primary Outcome Measures
Name Time Method Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone day 30
- Secondary Outcome Measures
Name Time Method Incidence of sternal wound infections at day 30 after cardiac surgery day 30
Trial Locations
- Locations (1)
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
🇩🇪Hannover, Germany