Antibiotic Prophylaxis in Orthopaedic Traumatology
Completed · Not applicable · Has a placebo group
Conditions studied: Fractures, Closed, Wounds and Injuries
In brief
It has been established that providing antibiotic prophylaxis after closed fracture fixation with implants or prosthetic devices has beneficial effects. However, the optimal duration of antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial effects of additional doses. Our proposed study is intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment of closed fractures. We will randomly assigned patients into two groups, hopefully differentiated only by the duration of antibiotic administration (single dose vs. 24 hours). We will follow these patients until fracture healing and determine if there is a difference in the incidence of infection.
Key facts
- Study ID
- NCT00610987
- Run by
- University of Missouri-Columbia
- People needed
- 178
- Starts
- 2008-01-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2015-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years or older;
- Scheduled for primary osteosynthesis or placement of a prosthetic device in the treatment of closed limb fractures;
- Ability to give informed consent.
You may not qualify if…
- Known hypersensitivity to cephalosporins;
- Antimicrobial use or symptoms of infection in the week before surgery;
- Pregnancy;
- Immunosuppressive treatment;
- Inability to give informed consent.
Where it is running
- University of Missouri — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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