Hudson E, Murahata R I
Global Clinical Research Hollister, Wokingham, UK.
Spinal Cord. 2005 Oct;43(10):611-4. doi: 10.1038/sj.sc.3101760.
This in vitro model was designed to determine whether using a no-touch method for catheter preparation and insertion would affect the degree of contamination transmitted to intermittent urinary catheters.
Northview Laboratories, Northbrook, IL 60062, USA.
This was a parallel experimental study conducted in vitro at an independent testing laboratory under Good Manufacturing Practices. Six different models of intermittent urinary catheter were tested in triplicate, in accordance with the manufacturer's Instructions For Use (IFU). Gloved hands were contaminated with a known amount of Staphylococcus aureus or Escherichia coli, preparation for insertion was mimicked according to the manufacturer's IFU. The number of bacteria transferred to the catheter was then quantified using a validated technique. The null hypothesis tested was that the bacterial contamination resulting from handling would be the same for all of the catheters. The primary outcome measure was the amount of bacteria, expressed as colony forming units (CFU), recovered from the catheters. The catheter wrappers were sampled to confirm that active transfer of microorganisms had taken place and nonhandled samples served as the negative controls.
For both test organisms, the number of bacteria recovered from the catheters was significantly lower (P < 0.05) for the catheters featuring the no-touch design (approximately 5 CFU/plate versus 2.1 x 10(2) to 4.4 x 10(2) for the traditional hydrophilic catheters). The bacterial recovery from those catheters with the no-touch design often fell below the nominal detection limit.
The results of this study allow the null hypothesis to be rejected; it can be concluded that the no-touch method provides a significant benefit in reducing the potential for external contamination of an intermittent urinary catheter. This result supports the recent recommendations for aseptic intermittent catheterization promoted within the guidelines issued by the European Association of Urologists (EAU).
设计此体外模型以确定采用无接触方法进行导尿管准备和插入是否会影响传递至间歇性导尿管的污染程度。
美国伊利诺伊州北布鲁克市诺斯维尤实验室,邮编60062。
这是一项在独立检测实验室按照良好生产规范进行的体外平行实验研究。按照制造商的使用说明书(IFU),对六种不同型号的间歇性导尿管进行了三次重复测试。戴手套的手沾染已知数量的金黄色葡萄球菌或大肠杆菌,根据制造商的IFU模拟插入准备过程。然后使用经过验证的技术对转移至导尿管的细菌数量进行量化。所检验的零假设是,所有导尿管因操作导致的细菌污染情况相同。主要结局指标是从导尿管中回收的细菌数量,以菌落形成单位(CFU)表示。对导尿管包装进行采样以确认微生物的主动转移已经发生,未处理的样本用作阴性对照。
对于两种测试微生物,采用无接触设计的导尿管从其回收的细菌数量显著更低(P < 0.05)(约5 CFU/平板,而传统亲水导尿管为2.1×10²至4.4×10²)。采用无接触设计的那些导尿管的细菌回收率常常低于名义检测限。
本研究结果可拒绝零假设;可以得出结论,无接触方法在降低间歇性导尿管外部污染可能性方面具有显著益处。这一结果支持了欧洲泌尿外科学会(EAU)发布的指南中近期对无菌间歇性导尿的推荐。