Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent.
研究概览
简要总结
The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).
- •Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone > 1 cm, renal stone > 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).
- •Patients who have or are going to have chronic ureteral stents, for any reason.
- •Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.
排除标准
- •Age ≤ 17 years
- •Patients unable to consent.
- •Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).
- •Pregnant females
- •Immunocompromised patients
- •Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis)
- •Anyone in the investigator's opinion that would be unsuitable.
研究组 & 干预措施
1
Percuflex Plus Ureteral Stent
干预措施: Ureteral Stent (Device)
2
TRIUMPH stent (triclosan-eluting stent)
干预措施: Ureteral Stent (Device)
结局指标
主要结局
Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent.
时间窗: at time of intervention
次要结局
- Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.(at time of intervention)
研究者
John Denstedt
Chair/Chief, Department of Surgery, Western University
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's