NCT05337566

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,278 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection Post Op
• Hysterectomy
• Antibiotics
• Prophylactic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-05
• Primary completion: 2025-12-01
• Completion: 2030-12-01
• First posted: 2022-04-20
• Last updated: 2024-08-21

Locations

6 sites across 1 country: Finland