Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHelsinki University Central Hospital

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

2,278 Participants
are divided into 2 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