NCT01841567已完成4 期
A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty
Molnlycke Health Care AB1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Minimize the Risk of the Development of Blistering.
研究概览
简要总结
The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45 years
- •Have an expected total length of stay of 4 or more days
- •Undergoing elective primary arthroplasty of the hip or knee
- •Undergoing hip surgery with a standard access
- •Give their written informed consent to participate
排除标准
- •Dressing size does not fit the incision area
- •Known allergy hypersensitivity to any of the components of the dressing
- •Multi-trauma
- •Undergoing arthroplasty due to tumour
- •Wound at the surgical site prior to surgery
- •Neurological deficit of operated side
- •Subject has documented skin disease at time of enrolment, as judged by the investigator
- •Previously enrolled in the present investigation
- •Subject included in other ongoing investigation at present, as judged by the investigator.
研究组 & 干预措施
dressing
Other
干预措施: Mepilex border post. op (Device)
dressing
Other
干预措施: Mepilex border post op (Device)
结局指标
主要结局
Minimize the Risk of the Development of Blistering.
时间窗: 7 days
Number of participants without blisters at study visit
次要结局
- Pain Evaluation(7 days)
- Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.(7 days)
- Comfort, Comformability, Acceptability of the Dressing(7 days)
- Overall Cost Regarding Dressing Wear Time(7 days)
研究者
研究点 (1)
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