Prospective, randomized, double-blind study comparing single-agent antibiotic therapy, ciprofloxacin, to combination antibiotic therapy in open fracture wounds.

摘要

OBJECTIVE: The purpose of this study was to compare the efficacy of a single agent, ciprofloxacin, with that of combination antibiotic therapy consisting of cefamandole and gentamicin in all types of open fracture wounds. STUDY DESIGN: A prospective double-blind randomized clinical trial. SETTING: A Level 1 trauma center. PATIENTS: One hundred ninety-five consecutive patients with 203 open fractures were enrolled over a twenty-month period. Twenty-nine fractures from low-velocity gunshot wounds were excluded, and three other patients were excluded because of protocol violations. Our final number of patients were 163, with 171 open fractures. MAIN OUTCOME MEASUREMENT: The infection rates for Type I and Type II open fractures for both antibiotic groups were calculated. The infection rate of Type III open fractures for both antibiotic groups was also calculated. Chi-square analysis with Yates correction was used to assess statistical significance of two treatment groups. RESULTS: The infection rate for Types I and II open fractures in the ciprofloxacin group was 5.8 percent and 6 percent for the cefamandole/gentamicin group (p = 1.000). The infection rate for Type III open fractures for the ciprofloxacin group was 31 percent (8 of 26) versus 7.7 percent (2 of 26) for the cefamandole/gentamicin group (p = 0.079). There were no statistically significant differences in infection rate between the group treated with ciprofloxacin and that treated with cefamandole/gentamicin for Types I and II open fracture wounds. However, there appeared to be a high failure rate for the ciprofloxacin Type III open fracture group, with patients being 5.33 times more likely to become infected than those in the combination therapy group. Although this difference was not statistically significant, possibly because of the small sample size, there was a definite trend toward statistical significance. CONCLUSION: Single-agent antibiotic therapy with ciprofloxacin is effective in treatment of Type I and Type II open fracture wounds. However, on the basis of our results, we cannot recommend ciprofloxacin alone for Type III wounds. Possibly one can use fluoroquinolones in combination therapy, specifically as an alternate to an aminoglycoside.