Placebo-controlled, double-blind, randomized study of prophylactic antibiotics in elective abdominal hysterectomy

To assess the efficacy of a single dose of ampicillin or cefazolin in preventing fever and infection after elective abdominal hysterectomy, we conducted a multicentre, randomized, double-blind, controlled trial at Srinagarind Hospital, Faculty of Medicine, Khon Kaen University and Khon Kaen Regional Hospital. Three hundred and thirty patients scheduled for elective abdominal hysterectomy were randomly allocated into either placebo, ampicillin or cefazolin groups. Patients received sterile water (3 mL) or ampicillin (1 g) or cefazolin (1 g) intravenously according to random assignment 30 min before the operation. After the operation, all patients were assessed by blinded independent evaluators until discharged from the hospitals. Our main outcome measures were postoperative fever and infectious morbidity. We found that 321 patients (97.3% of recruited patients) were available for data analysis, 108 in placebo, 106 in ampicillin and 107 in cefazolin group. Febrile morbidity occurred in 13/108 (12.0%), 14/106 (13.2%) and 12/107 (11.2%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was no statistically significant difference in febrile morbidity between the three groups. Infectious morbidity was found in 29/108 (26.9%), 24/106 (22.6%) and 11/107 (10.3%) of patients in the placebo, ampicillin and cefazolin groups, respectively. There was a statistically significant difference between the placebo and cefazolin groups (P = 0.002). Between the placebo and ampicillin groups, the result was not significantly different (P = 0.476). There was a statistically significant difference between the cefazolin and ampicillin groups (P = 0.015). The common causes of infectious morbidity were urinary tract infection, vaginal cuff infection and surgical wound infection. We concluded that antibiotic prophylaxis by cefazolin should be recommended for elective total abdominal hysterectomy.