Intra-operative antibiotic prophylaxis in neurosurgery. A prospective, randomized, controlled study on cefotiam.

In this prospective, randomized and controlled study the effect of cefotiam for the prevention of wound infections following trepanations was investigated. The main interest was centered on the rate of post-operative bone flap infections requiring operative revision. Administration of cefotiam was randomized for patients undergoing major craniotomies. The antibiotic was administered intravenously in a single dose of 2 g with induction of anaesthesia. Only clean or clean contaminated cases were included. Excluded were contaminated cases, operations with a transnasal-transsphenoidal approach, shunt-operations and patients with any other preoperative infection or antibiotic therapy. Outpatients were excluded due to difficulties in obtaining sufficient clinical information. From originally 918 consecutive patients operated on 711 fulfilled the entry criteria. With regard to age, sex, diagnosis and the site of te trepanation, control patients (n = 355) and cefotiam treated patients (n = 356) were shown to be comparable. In the various subgroups formed for different primary diagnoses, concomitant steroidal therapy and concomitant severe internal medical diseases cefotiam treated patients and controls were comparable as well. A highly significant difference for bone flap infection could be shown with 0.3% in the cefotiam group versus 5.1% in the control group (p less than 0.001). The overall rate of post-operative deep wound infections including meningitis and abscesses was also significantly (p less than 0.005) different with 3.1% in the cefotiam versus 9.0% in the control group. Thus it was concluded that a single dose of cefotiam significantly reduces post-operative deep wound infection.

RCT Entities:   Population Interventions Outcomes