EUCTR2014-000124-14-NLActive, not recruitingNot Applicable
Antibiotic prophylaxis to prevent wound infections following implant removal after foot, ankle and lower leg fractures. - WIFI trial
Academic Medical Center0 sitesStarted: October 21, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Consecutive patients of all ethnic backgrounds, aged 18 to 75 years, scheduled for implant removal
- •following foot, ankle and/or lower leg fracture surgery are included after written informed consent.
- •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 500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Exclusion criteria are: removal and re-implanting of osteosynthetic material in the same session; an active wound infection or (plate) fistula; antibiotic treatment at time of elective implant removal for a concomitant disease or infection; a medical history of an allergic reaction to a cephalosporin; insufficient comprehension of the Dutch language to understand the patient information to make an informed decision to participate.
Investigators
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