Background. The incidence of surgical site infection (SSI) after clean
surgical procedure has traditionally been regarded as too low for rou
tine antibiotic prophylaxis. But we now Know that host factors may inc
rease the risk of SSI to as high as 20%. We assessed the value of prop
hylactic cefotaxime in patients stratified for risk of SSI in a random
ized double-blind trial Methods. Patients admitted for clean elective
operations were enrolled, stratified for risk by National Nosocomial I
nfection Survey criteria, and randomized to receive intravenous cefota
xime 2 gm or placebo on call for operation. They were followed for 4 t
o 6 weeks for SSI diagnosed by Centers for Disease Control and Prevent
ion criteria. Results. Analysis of 775 patients showed that the 378 ev
aluable patients who received cefotaxime had 70% fewer SSIs than those
who did not-Mantel-Haenszel risk ratio (MH-RR) 0.31; 95% confidence i
ntervals (CI) 0.11 to 0.83. Benefit was clear in the 616 low risk pati
ents-0.97% versus 3.9% SSI (MK-RR 0.25, CI 0.07 to 0.87, p = 0.018), b
ut only a trend was seen in 136 high risk patients-2.8% versus 6.1% SS
I (MH-RR 0.48, CI 0.09 to 2.5). Conclusions. The results indicate clea
r benefit for routine antibiotic prophylaxis in clean surgical procedu
res. High risk patients need more study.