Status:
COMPLETED
Wound Infections Following Implant Removal
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
AO Research Fund
Conditions:
Surgical Wound Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical...
Detailed Description
See study protocol
Eligibility Criteria
Inclusion
- Patients ≥18 years and ≤75 years of all ethnic backgrounds
- Implant removal following foot, ankle and/or lower leg surgery
Exclusion
- Removing and re-implanting osteosynthesis material in the same session
- 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, penicillin, or any other β-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).
- Treatment with probenecide, anticoagulants (see SPC)
- Pregnancy and lactation
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02225821
Start Date
November 1 2014
End Date
November 1 2016
Last Update
December 22 2016
Active Locations (21)
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1
Medisch Centrum Alkmaar
Alkmaar, Netherlands
2
Flevoziekenhuis
Almere Stad, Netherlands
3
Amstelland Ziekenhuis
Amstelveen, Netherlands
4
Academic Medical Center
Amsterdam, Netherlands