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临床试验/NCT02820272
NCT02820272已完成2 期

Cold Water for Reducing Pain in Negative Pressure Wound Therapy Dressing Change

Chulalongkorn University0 个研究点目标入组 27 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
27
主要终点
Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)

研究概览

简要总结

Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound healing in complicated wound. However for many patients, the application and removal of the NPWT is source of procedural pain. Some techniques had been reported to reduce these pain such as administering topical lidocain or normal saline solution before the dressing change. The authors hypothesized that administering cold water into the NPWT sponge would decrease pain during dressing changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Open wounded patient who is treated by negative pressure wound therapy (NPWT) with the age between 18-70 years old.

排除标准

  • •The patient who has decrease sensation at cured wound region
  • •The patient who has Glasgow coma scale less than 15
  • •The patient who cannot provide pain scale data
  • •The patient who has diabetic ulcer or other chronic sores
  • •The patient who denies to participate in research project.

研究组 & 干预措施

NPWT without other intervention

Placebo Comparator

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was no injection of any liquids into sponge before dressing change.

干预措施: NPWT without other intervention (Procedure)

NPWT with cold water

Experimental

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was the intervention with injection of cold sterile water kept in 4°C temperature into sponge 10 minutes before dressing change.

干预措施: NPWT with cold water (Procedure)

NPWT with normal saline room temp

Active Comparator

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was the intervention with injection of room temperature sterile water kept in room temperature into sponge 10 minutes before dressing change.

干预措施: NPWT with normal saline room temp (Procedure)

结局指标

主要结局

Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)

时间窗: 3 days

次要结局

未报告次要终点

研究者

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

Apichai Angspatt

Principal Investigator

Chulalongkorn University

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