Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azithromycin Pill + Cefuroxime, Placebo + Cefuroxime.
- Who it may be relevant to
- Registry conditions: Infection Post Op, Hysterectomy, Antibiotics, Prophylactic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
Overview
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.
Interventions
- Drug Azithromycin Pill + Cefuroxime
Azithromycin 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 - Drug Placebo + Cefuroxime
Placebo (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
Primary outcome measures
- Number of post-hysterectomy episodes with deep infections [Time frame: Deep infections that occur between the first and 30th postoperative day after hysterectomy]
Secondary outcome measures (1)
- Number of other post-hysterectomy infections or fever episodes [Time frame: Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Finland · 6 centers
- Helsinki University Central Hospital — Helsinki
- Jyväskylä Central Hospital — Jyväskylä
- Kuopio University Central Hospital — Kuopio
- Oulu University Central Hospital — Oulu
- Tampere University Central Hospital — Tampere
- Turku University Central Hospital — Turku
Identifiers
NCT: NCT05337566 · HUS/117/2022 · 2021-003467-10