Novel Antimicrobial Solution to Prevent Infections

NCT07881822 — Not yet recruiting, 50 participants, Ohio State University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Prospective Trial of a Novel Antimicrobial Solution to Reduce Infections After Ureteroscopy

RegistryNCT07881822
StatusNot yet recruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorOhio State University (Other)
ConditionsKidney Stone, Infection, Infection Associated With Catheter, Sepsis
Interventionsantimicrobial irrigation (Drug)
Datesstart 2026-11-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-10-19, last updated 2026-10-19

Related Papers Related Patents Related Grants Related Experts
All trials for Kidney Stone All trials for Infection All trials of antimicrobial irrigation

-Summary

Ureteroscopy is the most common surgical treatment for kidney stones. Although rare, sepsis after ureteroscopy can be a life-threatening complication, occuring in <3% of patients. There are several risk factors for sepsis including history of positive urine culture, pre-existing ureteral stent, or patients with chronic catheters/tubes. We want to study if an antimicrobial solution with chlorhexidine can prevent infections if instilled into the kidney prior to starting ureteroscopy.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
ObservationalDrug: antimicrobial irrigationTreatment with antimicrobial solution
  • antimicrobial irrigation (Drug): antimicrobial irrigation to be used with ureteroscopy

+Outcome measures

Primary outcomes

  • Emergency room visits [90 days]: compare rates of ED visits in the prospective cohort to historic controls

Secondary outcomes

  • allergic reaction [30 days]: any reactions to the antimicrobial solution

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* candidate for ureteroscopic stone removal

Exclusion Criteria:

* < 18 years old
* women who are pregnant or breast feeding

+Publications

  • CDC: Summary of Recommendations. Infection Control 2024. Available at: https://www.cdc.gov/infection-control/hcp/cauti/summary-of-recommendations.html, accessed July 24, 2024. 2. Anon: Reducing unnecessary urinary catheter use and other strategies to prevent catheter-associated urinary tract infection: an integrative review | BMJ Quality & Safety. Available at: https://qualitysafety.bmj.com/content/23/4/277, accessed May 15, 2025. 3. Anon: Chlorhexidine Irrigation to Reduce Urinary Tract Infections in Patients with Bladder Cancer Undergoing Radical Cystectomy - NCI. 2016. Available at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2024-06347, accessed May 15, 2025. 4. Anon: Bladder instillation with Irrisept in Urinary Retention and Neurogenic Bladder - Clinical Trials Registry - ICH GCP. Available at: https://ichgcp.net/clinical-trials-registry/NCT06163469, accessed May 15, 2025.
  • Atkins L, Sallis A, Chadborn T, Shaw K, Schneider A, Hopkins S, Bunten A, Michie S, Lorencatto F. Reducing catheter-associated urinary tract infections: a systematic review of barriers and facilitators and strategic behavioural analysis of interventions. Implement Sci. 2020 Jul 6;15(1):44. doi: 10.1186/s13012-020-01001-2. PMID 32624002
  • Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147. PMID 23757735