Three hundred one patients were studied in ongoing, double-blinded, randomized clinical trials of the efficacy and safety of multiple-dose
cefoxitin and single-dose
cefonicid for the prevention of postoperative surgical
infection in patients undergoing elective biliary tract operations or
hysterectomy. In the biliary surgery trial, one patient (1.5%) of 66 assessable patients given
cefoxitin and three (4.7%) of 64 given
cefonicid developed incisional
infection of the abdominal
wound (P = not significant [NS] ). Two (6%) of 31 patients undergoing
vaginal hysterectomy who were given
cefoxitin and four (14%) of 29 given
cefonicid developed vaginal cuff
cellulitis (P = NS); three (6%) of 49 patients undergoing abdominal
hysterectomy who were given
cefoxitin and none of 37 given
cefonicid developed
pelvic cellulitis (P = NS). Adverse effects ascribable to one of the study drugs were infrequent and minor in both groups. Levels of
cefonicid in serum and the uterus or gallbladder wall 2-3 hr after the preoperative dose--before
wound closure--were high (mean, 30-40 micrograms/ml), values five to six times higher than those for
cefoxitin. The duration of postoperative hospitalization and the costs of hospital care for the two treatment groups were similar in both trials. These studies suggest that a single preoperative dose of
cefonicid provides protection against surgical
infection following biliary tract operations and
hysterectomy that is comparable to that provided by
cefoxitin given both preoperatively and 24 hr postoperatively.