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Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

RecruitingNAAges 18 Years - anyFemaleHelsinki University Central Hospital
NCT05337566 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-hy

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Use of medicines that may prolong Q-T-corrected interval (class Ia arrhythmia medications, quinidine, procainamide, and class III arrhythmia medications dofetilide, amiodarone and sotalol). * Use of selective serotonin reuptake inhibitor medication and prolonged Q-T-corrected interval.
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What it tests

  • Azithromycin Pill + Cefuroxime
  • Placebo + Cefuroxime
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Where

6 sites
Helsinki University Central Hospital
Helsinki, Finland
Jyväskylä Central Hospital
Jyväskylä, Finland
Kuopio University Central Hospital
Kuopio, Finland
Oulu University Central Hospital
Oulu, Finland
Tampere University Central Hospital
Tampere, Finland
Turku University Central Hospital
Turku, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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