Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Stopped early · Phase 4
Conditions studied: Catheter; Infection (Indwelling Catheter), Catheter Infection, Catheter-Related Infections, Catheter Bacteraemia, Urinary Tract Infections
In brief
Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Key facts
- Study ID
- NCT03447639
- Run by
- Corewell Health East
- People needed
- 3
- Starts
- 2018-03-29
- Expected to finish
- 2018-10-22
- Last updated by the study team
- 2020-01-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
- Male
- Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal
You may not qualify if…
- Patients planned for discharge with an indwelling catheter in place
- Patients unable to report urinary symptoms accurately
- Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
- Clinical signs or symptoms of urinary tract infection at the time of consent
- Patients currently being treated for UTI
- Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
- Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
- Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
- Patients unable to comply with study requirements
- Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data
Where it is running
- Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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