RecruitingNot ApplicableNCT05337566

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Infections After Hysterectomy - a Placebo-controlled Study Comparing the Prophylactic Use of Azithromycin and Cefuroxime With Single Cefuroxime


Sponsor

Helsinki University Central Hospital

Enrollment

2,278 participants

Start Date

Sep 5, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azithromycin Pill + Cefuroxime and a drug called Placebo + Cefuroxime for people with antibiotics, hysterectomy, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin 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

DRUGPlacebo + 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

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NCT05337566


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