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临床试验/NCT07817732
NCT07817732已完成不适用

Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2024年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Participant Recruitment Rate

研究概览

简要总结

Evidence regarding clinical effectiveness and acceptability of PICC sleeves remain limited. Few randomised controlled trials have evaluated PICC sleeves in routine hospital practice, and there is limited evidence regarding their feasibility, safety and influence on line condition. This pilot randomised controlled trial aims to evaluate the feasibility, safety, and user experience of a protective PICC sleeve among hospitalised patients with PICCs.

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
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients receiving PICC placement for various medical conditions

排除标准

  • Patients with known allergies to materials in the PICC sleeve
  • Patients contraindicated for PICC placement
  • Patients who are aggressive and/or restless
  • Patients whose skin condition is unsuitable for CHG gel dressing application (e.g. skin with eczema plaques, bullous pemphigoid)
  • Patients who have no mental capacity to give consent

研究组 & 干预措施

The control group

No Intervention

The control group used the standard securement dressing

The Treatment group

Experimental

The treatment group received appropriately sized PICC sleeve cover in addition to standard device securement practices.

干预措施: Novel PICC Sleeve Cover (Other)

结局指标

主要结局

Participant Recruitment Rate

时间窗: 16 months

Number of participants recruited over the recruitment period

次要结局

  • Intervention Adherence(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Retention of Study Participants across 3 Time-points(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Completeness of Data Collected(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Number of Adverse Events(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Patient-Reported Dislodgement Risk(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Patient-Reported Comfort Level(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Patient-Reported Visibility Level(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Patient-Reported User-friendliness(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Patient-Reported Acceptability Outcome(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Staff-Reported Dislodgement Risk(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Staff-Reported Comfort Level(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Staff-Reported Visibility Level(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Staff-Reported User-friendliness(From enrolment to 7 days after discharge or upon removal, whichever earlier.)
  • Staff-Reported Acceptability Outcome(From enrolment to 7 days after discharge or upon removal, whichever earlier.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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