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RECRUITING
NCT05337566
NA

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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

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

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