ABSTRACT
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.
