Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
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
- 否
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
The control group used the standard securement dressing
The Treatment group
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.)
