Study to Reduce Post-Hysterectomy Infections Using Azithromycin and Cefuroxime Compared to Cefuroxime Alone

What this Trial Is About

Researchers are evaluating whether adding azithromycin to the usual antibiotic cefuroxime before hysterectomy can reduce infections that occur after the surgery. The study focuses on women undergoing hysterectomy for non-cancerous reasons and aims to see if this combination lowers the risk of deep infections within 30 days post-operation. It also looks at other infections like superficial wound infections, urinary tract infections, fever episodes, and possible side effects of these antibiotics. Additionally, the study investigates the role of bacterial vaginosis and the vaginal microbiome in these infections. Participants are randomly assigned to receive either azithromycin 500 mg orally when they arrive at the hospital on the day of surgery plus a single dose of cefuroxime 1.5g for those with body mass index under 30 or 3g for BMI 30 or above before the surgical incision, or a placebo plus the same cefuroxime dose. The azithromycin or placebo is given as two tablets by mouth, and the cefuroxime is given once intravenously in the operating room. This design is triple-blinded to compare the effects fairly. During the study, researchers monitor participants for signs of deep infections or other infections and fever from day 1 to day 30 after hysterectomy. Assessments include clinical evaluations and possibly electrocardiograms to check heart rhythm safety. The main outcome measured is the number of deep infections occurring within 30 days post-surgery. The study runs until December 2030, with participants followed closely during this 30-day period to track infections and any side effects from the antibiotics.

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections