Characterisation of Biofilm Growth on Coated vs. Uncoated Urinary Catheter Surfaces in Normal Clinical Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The primary outcome is the percentage of catheter surface colonised by biofilm, calculated as (light / (light + dark) x 100% in measurement of stained samples using fluorescence microscopy.
研究概览
简要总结
- Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised)
Selection follows documented hospital protocols for routine catheterisation 2. Measured Patients: 30 patients (Convenience sample: non-blinded and non-randomised)
- 20 who receive the M4D coated catheter.
- 10 who receive the standard uncoated catheters used in routine patient care.
详细描述
- Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised)
Selection follows documented hospital protocols for routine catheterisation 2. Measured Patients: 30 patients (Convenience sample: non-blinded and non-randomised)
- 20 who receive the M4D coated catheter.
- 10 who receive the standard uncoated catheters used in routine patient care.
- Evaluation (5 patients, coated catheter)
A convenience sample of patients will be selected to receive the Camstent coated catheter for their routine care. These enrolments are drawn from among those recommended for routine catheterisation, for up to 28 days and in accordance to existing hospital protocols. There is no change to the routine protocols for insertion, maintenance, withdrawal, or documentation of the patient's catheterisation. Following use, the catheter is discarded according to the hospital's procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- •• Patients under age
- •Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
- •Patients who they have had previous radiation therapy in lower pelvis.
- •Patients who are cognitively impaired, or are unwilling to give consent
- •Patients with a potentially immunocompromised condition
- •Patients that require further antibiotics after initial dose, or those that are administered antibiotics following an infection whilst the trial urinary catheter is in situ
研究组 & 干预措施
Standard of Care
Standard of Care
干预措施: Standard of Care (Device)
M4D coated catheter
Experimental
干预措施: M4D (Device)
结局指标
主要结局
The primary outcome is the percentage of catheter surface colonised by biofilm, calculated as (light / (light + dark) x 100% in measurement of stained samples using fluorescence microscopy.
时间窗: 30 days
The primary outcome is the percentage of catheter surface colonised by biofilm, calculated as (light / (light + dark) x 100% in measurement of stained samples using fluorescence microscopy.
次要结局
- Secondary outcomes will be logging of events, including catheter blockage or presumed CAUTI.(30days)