Antibiotic prophylaxis and prevention of wound infections following implant removal after foot, ankle and lower leg fractures
Phase 4
Completed
- Conditions
- postoperative wound infection100173221004078510005944
- Registration Number
- NL-OMON44330
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Implant removal in foot, ankle and lower leg in patients *18 years and *75 years of all ethnic backgrounds
Exclusion Criteria
- Removing and re-implanting material in the same session
- Implant removal due to active infection
- Implant removal due to a (plate) fistula
- Current antibiotic treatment
- Allergy to cephalosporines
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the incidence of wound infection (within 30 days after<br /><br>implant removal) as defined by the criteria applied by the CDC<br /><br>and diagnosed by the attending physician.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are health-related quality of life (as measured by the<br /><br>EQ-5D), functional outcome (assessed with the Lower Extremity<br /><br>Functional Scale), patient satisfaction (measured by a ten-point Visual Analog<br /><br>Scale), several treatment and function related items (including<br /><br>amongst others, number of visits to the general practitioner and use of home<br /><br>care organizations) measured at 30 days and 6 months<br /><br>postoperatively, as well as costs (e.g. production losses due to sick leave).<br /><br>In addition, the incidence of micro-bacterial growth in cultures taken<br /><br>peroperatively (evaluation between patients with and without antibiotic<br /><br>prophylaxis) and diversity of micro bacterial growth in postoperative wound<br /><br>infection will be documented.</p><br>