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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,278
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 (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
Helsinki University Central Hospital
Helsinki, Finland
RECRUITINGJyväskylä Central Hospital
Jyväskylä, Finland
RECRUITINGKuopio University Central Hospital
Kuopio, Finland
RECRUITINGOulu University Central Hospital
Oulu, Finland
RECRUITINGTampere University Central Hospital
Tampere, Finland
RECRUITINGTurku University Central Hospital
Turku, Finland
RECRUITINGNumber 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 hysterectomy
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.
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