Preventing Infections in Orthopaedic Patients
- Conditions
- Open Fracture
- Registration Number
- NCT02948387
- Lead Sponsor
- Olayemi Osiyemi MD
- Brief Summary
Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.
- Detailed Description
1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
2. Identify the incidence of acute kidney injury.
3. Identify the type and number of associated infections
4. Identify the antibiotic resistance profile noted
5. Identify any secondary infections at sites other than the fracture site
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Male or Female >= 18 years old
- Patients are diagnosed with a Type II or III open fracture
- Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
- pregnancy
- did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
- receiving ongoing inpatient care
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of fracture site infections 30 days number of infections
- Secondary Outcome Measures
Name Time Method Incidence of acute renal injury 30 days number of patients with worsening renal function from baseline
number of secondary infections at site other than fracture sites 30 days describe the number infections at secondary sites
type of bacteria infection 30 days name of bacteria infection
resistance trend in patients with infections 30 days describe the number of MDRO infections
Trial Locations
- Locations (1)
Triple O Research Institute PA
🇺🇸West Palm Beach, Florida, United States