N/A
Completed N=146
Antibiotic Prophylaxis in Orthopaedic Traumatology
Fractures, Closed · Wounds and Injuries
Source: ClinicalTrials.gov NCT00610987 ↗
Enrolled (actual)
146
Serious AEs
27.4%
Results posted
Jun 2015
Primary outcomePrimary: Number of Participants With Total Wound Infections — 4; 9 participants — p==0.12
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Total Wound Infections |
4; 9 | =0.12 |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Known hypersensitivity to cephalosporins;
- Antimicrobial use or symptoms of infection in the week before surgery;
- Pregnancy;
- Immunosuppressive treatment;
- Inability to give informed consent.
Data sourced from ClinicalTrials.gov (NCT00610987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.