Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Hannover Medical School650 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

650

Conditions

Wound Infection

Interventions

DaptomycinDRUG

one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis

CefuroximeDRUG

1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery

Hanover, Germany

Outcomes

Primary Outcomes

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

Time frame: day 30

Secondary Outcomes

Incidence of sternal wound infections at day 30 after cardiac surgery

Time frame: day 30

Data from ClinicalTrials.gov

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