TArget-Site Concentrations of prophylactic cefazolin in foot and Ankle surgery
Phase 3
Withdrawn
- Conditions
- 'surgical site infection' 'postoperative wound infection'100173221004078510005944
- Registration Number
- NL-OMON46781
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- >17 years old
- Undergoing open surgery of the foot or ankle
Exclusion Criteria
- Antibiotic treatment within 7 days before the surgery
- An open fracture
- A medical history of an allergic reaction to a cephalosporin or severe reaction to penicillin, or any other *-lactam antibiotic
- Insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate
- Kidney disease (eGFR <60 ml/min/1.73m^2)
- Pregnancy and lactation
- A medical history of Diabetes Mellitus or serious peripheral vascular disease (* Fontaine III)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: fT>MIC at the 'target-site'</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome: fT>MIC in serum, rate of SSI, correlation between fT>MIC and<br /><br>infection </p><br>