Clinical Trial

Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Recruiting
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Record status
This record was last updated August 21, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-04-14; most recent amendment 2024-08-19.
Status change: Not Yet Recruiting → Recruiting 2022-09-05
Trial Details
NCT Number NCT05337566
Lead Sponsor Helsinki University Central Hospital
Collaborators: University of Turku, Tampere University Hospital, Kuopio University Hospital, Oulu University Hospital, Jyväskylä Central Hospital
Conditions Infection Post Op, Hysterectomy, Antibiotics, Prophylactic
Enrollment 2,278 participants
Start Date 2022-09-05
Primary Completion 2025-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-21