Open Fracture
Conditions
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
Interventions
None listed
Sponsors
Forest Laboratories
Olayemi Osiyemi MD
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female \>= 18 years old * Patients are diagnosed with a Type II or III open fracture
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of fracture site infections | 30 days | number of infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute renal injury | 30 days | number of patients with worsening renal function from baseline |
| type of bacteria infection | 30 days | name of bacteria infection |
| resistance trend in patients with infections | 30 days | describe the number of MDRO infections |
| number of secondary infections at site other than fracture sites | 30 days | describe the number infections at secondary sites |
Countries
United States
Contacts
Primary ContactPaul Glickman
Backup ContactOlayemi Osiyemi, MD
Outcome results
None listed