Prophylactic antibiotics in open fractures: a pilot randomized clinical safety study.

OBJECTIVE: To develop preliminary data on Staphylococcus aureus colonization and surgical site infections (SSIs) in patients with open fractures who received standard antibiotic prophylaxis compared with a regimen including targeted methicillin-resistant Staphylococcus aureus (MRSA) coverage.

DESIGN: Randomized prospective clinical trial.

PATIENTS: Adult patients who presented to the emergency department with an open fracture between April 2009 and July 2011.

INTERVENTIONS: One hundred thirty patients were randomized to receive prophylaxis with either cefazolin alone (control arm) or vancomycin and cefazolin (experimental arm) from presentation to the emergency department until 24 hours after the surgical intervention. Screening for S. aureus carriage was performed with nares swabs and predebridement and postdebridement open fracture wound swabs. Patients underwent prospective assessment for the development of SSI for no less than 30 days and up to 12 months.

RESULTS: Nasal colonization of methicillin-sensitive S. aureus and MRSA among the sample was 20% and 3%, respectively. No significant difference in the rates of SSI was observed between the study arms (15% vs 19%, respectively, P = 0.62). Staphylococcus aureus caused 55% of the deep incisional/organ space SSI, with 18% attributed to MRSA. A significantly higher rate of MRSA SSIs was observed among MRSA carriers compared with noncarriers (33% vs 1%, respectively, P = 0.003).

CONCLUSIONS: Staphylococcus aureus nasal colonization in trauma patients with open fractures is similar to that of the general community. In this pilot study, the addition of vancomycin to standard antibiotic prophylaxis was found safe, but its efficacy should be evaluated in a larger multiinstitutional trial.