Voorkomen van wondinfecties bij verwijderen van lichaamsvreemd materiaal onder de knie.
Recruiting
- Conditions
- Implant removalWound infectionAntibiotic prophylaxisFunctional outcomeVerwijderen van osteosynthesemateriaalPostoperatieve wondinfectieAntibiotca profylaxeFunctionele uitkomst
- Registration Number
- NL-OMON28685
- Lead Sponsor
- Academisch Medisch CentrumAmsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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 The primary outcome is the incidence of wound infections (within 30 days after implant removal) as defined by the criteria applied by the CDC and diagnosed by the attending physician.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are health-related quality of life (as measured by the EQ-5D), functional outcome (assessed with the Lower Extremity Functional Scale), patient satisfaction (measured by a ten-point Visual Analog Scale), several treatment and function related items (including amongst others, number of visits to the general practitioner and use of home care organizations) measured at 30 days and 6 months postoperatively, as well as costs (e.g. production losses due to sick leave).<br>In addition, the incidence of micro-bacterial growth in cultures taken peroperatively (evaluation between patients with and without antibiotic prophylaxis) and diversity of micro bacterial growth in postoperative wound infection will be documented.