Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
试验速览
- 阶段
- 不适用
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- exit-site infection
研究概览
简要总结
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
详细描述
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.
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
- •age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.
排除标准
- •current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally
研究组 & 干预措施
Semi-permeable film dressing
Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.
干预措施: semi-permeable film (Device)
sterile gauze and tape dressing
Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
干预措施: sterile gauze and tape (Device)
结局指标
主要结局
exit-site infection
时间窗: before disinfectant and dressing change at every hemodialysis session within 2 weeks
redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin
次要结局
- catheter-related blood stream infection(CRBSI)(within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks)
- skin erythema and dryness under the dressing area(before disinfectant and dressing change at every hemodialysis session within 2 weeks)
- dressing intactness(before disinfectant and dressing change at every hemodialysis session within 2 weeks)
- total bacterial count(Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session))
- nursing time for dressing change(at any of the session, once only)
研究者
Liang Junqing
nurse
Peking University People's Hospital