About this trial
This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
Eligibility criteria
Qualifiers
Age 18-75 years.
Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
Scheduled to undergo fURS lithotripsy.
No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
Disqualifiers
Pregnant or lactating women.
Allergy to the investigational drug(s).
Participation in other clinical trials within 30 days.
Presence of other active infection foci requiring antimicrobial treatment.
Trial design
Treatments tested in this trial
- not use any prophylactic antimicrobials
- use prophylactic antimicrobials