Prospektive, randomisierte, monozentrische 2-armige Studie zum Einsatz von Daptomycin in der antibiotischen Prophylaxe von sternalen Wundinfektionen nach medianer Sternotomie - DaPro - Daptomycin in der antibiotischen Prophylaxe sternaler Wundinfektione

• Conditions: Incidence of sternal wound infections after cardiac surgery via median sternectomy and use of the heart-lung machine.; MedDRA version: 9.1Level: LLTClassification code 10036410Term: Postoperative wound infection; MedDRA version: 9.1Level: LLTClassification code 10053562Term: Surgical wound infection; MedDRA version: 9.1Level: LLTClassification code 10054091Term: Wound infection due to staphylococcus aureus; MedDRA version: 9.1Level: LLTClassification code 10059442Term: Wound infection staphylococcal; MedDRA version: 9.1Level: LLTClassification code 10063528Term: MRSA wound infection; MedDRA version: 9.1Level: LLTClassification code 10065240Term: Wound infection bacterial

• Registration Number: EUCTR2007-004611-61-DE
• Lead Sponsor: Medizinische Hochschule Hannover (MHH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-31
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

* female and male patients having a cardiac surgery involving median sternectomy and the use of the heart-lung-machine

* age: 18 - 65 years

* written IC
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* pregnant and lactating women

* patients operated for a transplantation

* patients with a increased myopathy risk

* patients with a creatinine clearance < 30 ml/min; patients on hemodialysis

* patients after a previous sternectomy

* treatment with any antibioticum 14 days prior study start

* treatment with Daptomycin or Cefuroxim within 3 month prior study start

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified