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OpenTrials
Completed

NCT Number: NCT01080963

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

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.

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Key information

Conditions

Wound Infection Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Hanover, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

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

Other names: Cubicin

cefuroxime

Drug

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

Primary outcomes

  1. 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

  1. Incidence of sternal wound infections at day 30 after cardiac surgery

    Time frame: day 30

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Novartis

Registry information

Official study title

Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

Acronym: DaPro

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2010
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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