Comparative clinical and pharmacokinetic aspects of cefotetan versus cefoxitin plus metronidazole in vaginal hysterectomy.

In a randomised clinical trial, 102 women who underwent vaginal hysterectomy were given a single preoperative 2g dose of cefotetan (CTT) (52 pts) or three perioperative 2g doses of cefoxitin (CFX) plus 0.5g metronidazole (50 pts) as antibiotic prophylaxis. No statistically significant differences between the groups were detected in the clinical response (100% for both groups). The incidence of major wound infection (2% CTT and 0% CFX) were also comparable between the two treatment groups; post-operative changes in body temperature, duration of hospitalisation and post-operative urinary tract infections (16% CTT and 20% CFX) were similar. Both drugs were well tolerated. Twenty nine of the 102 patients were further investigated to determine the pharmacokinetics following a single 2g dose of CTT or CFX, in both serum and tissue. Although both antibiotics provided good concentrations during the early phase of surgery, CTT levels persisted for a longer time period. These results confirm that single dose cefotetan is equally as effective and safe as multiple dose cefoxitin plus metronidazole for prophylaxis in patients undergoing vaginal hysterectomy.

RCT Entities:   Population Interventions Outcomes