Hysterectomy Clinical Trial
Official title:
Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
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.
Status | Recruiting |
Enrollment | 2278 |
Est. completion date | December 2030 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital | Helsinki | |
Finland | Kuopio University Central Hospital | Kuopio | |
Finland | Oulu University Central Hospital | Oulu | |
Finland | Tampere University Central Hospital | Tampere | |
Finland | Turku University Central Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, University of Turku |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of post-hysterectomy episodes with deep infections | Number of deep wound and pelvic organ infection episodes reported by patients and doctors | Deep infections that occur between the first and 30th postoperative day after hysterectomy | |
Secondary | 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 | Number of other infections or fever episodes that occur between the first and 30th postoperative day after hysterectomy. |
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