Infection prophylaxy in open tibial fractures. Pefloxacine versus Cefazolin-Oxacilline. A 616 cases randomised study

The purpose of the study Was to compare the efficacy of a single 800 mg inj ection of Pefloxacin (PF) versus 2 days of cefazolin (1 gr.Q.6 H) followed by 3 days of oxacillin (1 gr.Q.8 H) in patients with an open tibial fractur e and to examine the predictive factors for infection. A double-blind doubl e dummy, multicentric, randomized trial was performed. 616 adults with an o pen tibial fracture requiring single-stage bone coverage were included. The end point was wound infection within 3 months. Results Within 3 months, 21/316 patients were infected in the PF group (6.6 p. 100) versus 24/300 in the CZ-OX group (8 p. 100), the difference was no t significant (95 p. 100 CI for difference: -4.8 p. 100 to 2.1 p. 100). Twe nty one strains were isolated in 18 infected patients In the PF group, and 27 in 20 patients in the CZ-OX group. Negative gram bacteria were less freq uent in the PF group (10 p. 100) than in the CZ-OX group (48 p. 100), and p ositive gram bacteria were more frequent in the PF group (90 p. 100) than i n the CZ-OX group (52 p. 100). Independent risk factors for infection were severe contamination, widespread contusion, unstable fracture, positive sam ple in the emergency room and at the end of surgery. Resistant infecting ba cteria rate was 24 p. 100 in infected cases. Conclusion There was no difference in infection rates after surgery for ope n tibial fractures between a 800 mg injection of Pefloxacin and 2 days of p ephazolin followed by 3 days of oxacillin. Infecting bacteria were mainly n osocomially acquired.