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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Azithromycin Pill + Cefuroxime
DrugAzithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Placebo + Cefuroxime
DrugPlacebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision
Treatment groups
2,278 Participants
are divided into 2 treatment groupsGroup A: Azithromycin + CefuroximeExperimental treatment 1 intervention
Group B: Placebo + CefuroximeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of post-hysterectomy episodes with deep infections
Number of deep wound and pelvic organ infection episodes reported by patients and doctors
Time frame
Deep infections that occur between the first and 30th postoperative day after hysterectomySecondary outcomes
1
Number of other post-hysterectomy infections or fever episodes
Number of superficial infections, other infections, such has urine tract infections, or fever episodes lasting over 38 ℃ over 2 days
Time frame
Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.Sponsors and contacts
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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
Source ClinicalTrials.gov