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临床试验/NCT01952964
NCT01952964Unknown不适用

The Effectiveness of a Physical Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients

The Queen Elizabeth Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
The effectiveness of spray dressing in preventing exit site infection

研究概览

简要总结

The present study aims to compare the differences in exit site infection between patients receiving spray dressing and conventional care. The outcome measures including catheter exit site infection rate, skin allergy, catheter damage and patient satisfaction

详细描述

Methods

The study will be conducted using randomized controlled trial.

Sampling

The subjects will be the patients with Tenckhoff Catheter recruited from the renal team in a regional acute hospital and a satellite dialysis centre. The sampling method will be convenience sampling. The subjects will be recruited sequentially after the insertion of Tenckhoff Catheter.

Inclusion criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

入选标准

  • Patient with established Tenckhoff Catheter for at least 3 months with skin healed satisfactorily

排除标准

  • Patient presents with signs and symptoms of exit site infection e.g. purulent discharge, pain, and swab of exit cultured with positive growth.
  • Patient with unhealed exit site.
  • Patient currently requires antibiotics
  • Patient shows sensitive to JUC Spray Dressing or 0.05% Chlorhexidine solution

结局指标

主要结局

The effectiveness of spray dressing in preventing exit site infection

时间窗: On going monitoring for six months

sign and symptom of red, tenderness, hot and discharge.

Prevention of infection

时间窗: Monitor the exit site for six months

Exit site infection

次要结局

  • Prevention of skin allergy(6 month monitoring)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TAM MEE LING BONNIE

Ms

The Queen Elizabeth Hospital

研究点 (2)

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