About this trial
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.
Eligibility criteria
Qualifiers
Women undergoing hysterectomy for benign indication in University Hospitals (Helsinki University Hospital, Turku University Hospital, Tampere University Hospital, Oulu University Hospital and Kuopio University Hospital) who have not any contraindications for azithromycin or cefuroxime.
Disqualifiers
Inability to understand the study protocol.
Allergy for either cefuroxime or azithromycin.
Congenital or acquired prolonged Q-T-corrected interval. All the participants will be asked about arrhythmias and whether they have congenital arrhythmias in the family,
Electrocardiogram will be checked for all the participants.
Trial design
Treatments tested in this trial
- Azithromycin Pill + Cefuroxime
- Placebo + Cefuroxime
Treatment groups
Sponsors and collaborators
Helsinki University Central Hospital
Lead sponsor
University of Turku
Collaborator
Tampere University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Jyväskylä Central Hospital
Collaborator