Antibiotic prevention of infections complicating radical abdominal hysterectomy.

In this randomized, double-blind study, the effectiveness of a single-agent prophylactic antibiotic in reducing infections after radical abdominal hysterectomy with pelvic and para-aortic lymphadenectomy was compared with a placebo. A total of 12 doses of cefoxitin (2g) or placebo were given to 70 patients, starting the evening before surgery. Because of tumor spread beyond the cervix, radical hysterectomy was not performed in 17 patients who were, therefore, excluded from the study. Analysis of 53 patients who completed the study revealed that 15% of cefoxitin patients had surgical site-related infections compared with 52% of placebo patients (P = .005). Significant differences between the groups were also observed in nonsurgical site-related infections (23 versus 48%), overall morbidity (58 versus 89%), and the need for additional antibiotic therapy (38 versus 67%). Socioeconomic status was a significant risk factor with 57% of staff patients demonstrating increased site-related infections as compared with 17% of private patients (P = .002). No clinically significant side effects were observed. The authors recommend the use of antibiotic prophylaxis in patients undergoing radical abdominal hysterectomy for gynecologic malignancies.

RCT Entities:   Population Interventions Outcomes