drugset / Trial / NCT05337566

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

NCT05337566

RandomizedParallel-groupTriple-blindPrevention

Summary

During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.

Timeline

Start
2022-09-05
Primary completion
2025-12
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 500 mg Oral
Background Cefuroxime Small molecule 1.5 g
Background Cefuroxime Small molecule 3 g

Indications

No indication recorded.