BACKGROUND: The use of prophylactic antibiotics has been shown to decrease the rate of surgical-site infections after clean neurosurgical operations, although previous clinical trials have provided no evidence that one antibiotic is superior to another for this purpose. OBJECTIVE: This study was undertaken to compare the rates of postoperative infectious complications of neurosurgery with prophylactic ceftriaxone and ampicillin/sulbactam, a less-expensive antibiotic. METHODS:Consecutive patients undergoing neurosurgery between January and December 1998 were recruited for the study. Those who had an infectious disease for which antibiotics were required, who received antibiotics within 48 hours before surgery, were aged <12 or >85 years, had an indwelling catheter for the monitoring of intracranial pressure, or had a history of allergy to the study drugs were excluded. Before the operation, eligible patients were randomized to either ampicillin/sulbactam 3 g or ceftriaxone 2 g. Surgeons and patients were blinded to treatment assignment. The study drugs were administered by the anesthesiologist as an IV bolus after induction of general anesthesia. All patients were followed for 6 weeks postoperatively. If reoperation was required within 6 weeks of the original operation, the patient received the same antibiotic as during the first surgery, without further randomization. RESULTS: Over the 1-year study period, 180 consecutive patients undergoing neurosurgical operations were recruited. Surgical-site infection occurred in 2 (2.3%) patients in the ampicillin/sulbactam group and 3 (3.3%) in the ceftriaxone group; nonsurgical-site infection occurred in 25 (28.4%) patients in the ampicillin/sulbactam group and 15 (16.3%) in the ceftriaxone group. The between-group differences were not statistically significant, with the exception of surgical implantation of foreign material, which was performed sig- nificantly more frequently in the ceftriaxone group (P = 0.045). In addition, 2 of 3 surgical-site infections in the ceftriaxone group involved foreign-material implantation; however, if these operations are omitted from the analysis, the difference between treatments remains nonsignificant. CONCLUSIONS: The results suggest that ampicillin/sulbactam and ceftriaxone are of similar prophylactic efficacy in clean neurosurgical operations. Because the acquisition cost of 2 g ceftriaxone is approximately 3 times greater than that of 3 g ampicillin/sulbactam, the latter may be more cost-effective than the former for neurosurgical prophylaxis; however, other relevant hospital-related costs were not assessed in this study.
RCT Entities:
BACKGROUND: The use of prophylactic antibiotics has been shown to decrease the rate of surgical-site infections after clean neurosurgical operations, although previous clinical trials have provided no evidence that one antibiotic is superior to another for this purpose. OBJECTIVE: This study was undertaken to compare the rates of postoperative infectious complications of neurosurgery with prophylactic ceftriaxone and ampicillin/sulbactam, a less-expensive antibiotic. METHODS: Consecutive patients undergoing neurosurgery between January and December 1998 were recruited for the study. Those who had an infectious disease for which antibiotics were required, who received antibiotics within 48 hours before surgery, were aged <12 or >85 years, had an indwelling catheter for the monitoring of intracranial pressure, or had a history of allergy to the study drugs were excluded. Before the operation, eligible patients were randomized to either ampicillin/sulbactam 3 g or ceftriaxone 2 g. Surgeons and patients were blinded to treatment assignment. The study drugs were administered by the anesthesiologist as an IV bolus after induction of general anesthesia. All patients were followed for 6 weeks postoperatively. If reoperation was required within 6 weeks of the original operation, the patient received the same antibiotic as during the first surgery, without further randomization. RESULTS: Over the 1-year study period, 180 consecutive patients undergoing neurosurgical operations were recruited. Surgical-site infection occurred in 2 (2.3%) patients in the ampicillin/sulbactam group and 3 (3.3%) in the ceftriaxone group; nonsurgical-site infection occurred in 25 (28.4%) patients in the ampicillin/sulbactam group and 15 (16.3%) in the ceftriaxone group. The between-group differences were not statistically significant, with the exception of surgical implantation of foreign material, which was performed sig- nificantly more frequently in the ceftriaxone group (P = 0.045). In addition, 2 of 3 surgical-site infections in the ceftriaxone group involved foreign-material implantation; however, if these operations are omitted from the analysis, the difference between treatments remains nonsignificant. CONCLUSIONS: The results suggest that ampicillin/sulbactam and ceftriaxone are of similar prophylactic efficacy in clean neurosurgical operations. Because the acquisition cost of 2 g ceftriaxone is approximately 3 times greater than that of 3 g ampicillin/sulbactam, the latter may be more cost-effective than the former for neurosurgical prophylaxis; however, other relevant hospital-related costs were not assessed in this study.