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Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections
Sponsor: Helsinki University Central Hospital
Summary
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.
Official title: Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2278
Start Date
2022-09-05
Completion Date
2030-12
Last Updated
2024-08-21
Healthy Volunteers
No
Interventions
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
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
Locations (6)
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