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Clinical Trials/EUCTR2014-000124-14-NL
EUCTR2014-000124-14-NL
Active, not recruiting
Not Applicable

Antibiotic prophylaxis to prevent wound infections following implant removal after foot, ankle and lower leg fractures. - WIFI trial

Academic Medical Center0 sitesOctober 21, 2014
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ConditionsPostoperative wound infection following implant removal below the kneeTherapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsCefalozin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative wound infection following implant removal below the knee
Sponsor
Academic Medical Center
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 21, 2014
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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