Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter
Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Junqing Liang, Graduate
- 电话号码：8832 +8615201091164
- 邮箱：yinpin777@126.com
学习地点
-
-
Beijing
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Beijing、Beijing、中国、100044
- 招聘中
- Peking University People's Hospital
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副研究员：
- Ying Wang
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接触：
- Junqing Liang, Graduate
- 电话号码：+8615201091164
- 邮箱：yinpin777@126.com
-
副研究员：
- Weilin Zhang
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副研究员：
- Yuxiao Yang
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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Experiment group use semi-permeable film 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.
|
|
其他：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.
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Control group use sterile gauze and tape 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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
exit-site infection
大体时间：before disinfectant and dressing change at every hemodialysis session within 2 weeks
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redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin
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before disinfectant and dressing change at every hemodialysis session within 2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
catheter-related blood stream infection(CRBSI)
大体时间：within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
|
At least one blood culture from peripheral venous puncture was collected at CVC removal and whenever a catheter-related infection or other type of sepsis was suspected (temperature 38.2°C or 36.5°C or chills, leukocytes 10,000 or 4,000, or other signs of sepsis according the diagnosis of CDC
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within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
|
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skin erythema and dryness under the dressing area
大体时间：before disinfectant and dressing change at every hemodialysis session within 2 weeks
|
The following scale was used for erythema [modified from Fitzpatrick et al. (20)]: 0 ¼ none; 0.5 ¼ equivocal erythema; 1 ¼ slight redness, spotty and diffuse; 2 ¼ moderate uniform redness; 3 ¼ intense redness; 4 ¼ fiery red with oedema.The following scale was used for dryness:0 ¼ none; 1 ¼ slight scaling, dryness; 2 ¼ moderate scaling, dryness; 3 ¼ severe dryness with large flakes.
The sum score of dryness and erythema over all assessment times served as outcome parameter.
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before disinfectant and dressing change at every hemodialysis session within 2 weeks
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total bacterial count
大体时间：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)
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cotton swab in skin within 2 cm around the exit-site of CVC under the dressing
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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)
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dressing intactness
大体时间：before disinfectant and dressing change at every hemodialysis session within 2 weeks
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if all the corners or edges of dressing is intact, count how many corners or edges rolled up or fell off
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before disinfectant and dressing change at every hemodialysis session within 2 weeks
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nursing time for dressing change
大体时间：at any of the session, once only
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how much time a dressing change procedure cost in minutes.
Nursing time are recorded by other nurse using a clock while the nurse change dressing for a patient.the
whole time cost of the nurse doing dressing change should be the outcome.
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at any of the session, once only
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合作者和调查者
调查人员
- 研究主任：Liangying Gan、Department of Nephrology, Peking University People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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