A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blistering
研究概览
简要总结
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects after hip or knee arthroplasty or spinal surgery in comparison to a standard wound dressing The secondary objectives are to evaluate:
- the performance of the dressing
- the comfort, conformability and the acceptability of the dressing
- pain before, during and after dressing removal
- the overall cost regarding dressing wear time, time to do dressing change and personal resources needed
详细描述
A monocentre, post CE-mark, randomized clinical trial will be conducted at the University of Cologne, Department of Orthopedics and Trauma Surgery.
Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up).
Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
AEs/ADEs/unexpected events with the device may be documented by relevant photos at time. All photos shall include a sticker marked with subject code, visit number/date and time.
Outcome Measures
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18years
- •Have an expected total length of stay of 4 or more days
- •Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
- •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 or spine surgery due to tumour or infection?
- •Wound at the surgical site prior to surgery
- •Neurological deficit of operated side (hemiplegia, etc.)
- •Subject has documented skin disease at time of enrolment, as judged by the investigator
结局指标
主要结局
Blistering
时间窗: 0-6 days
Development of blistering from day 0 to day 6 post surgery Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
次要结局
- performance and acceptability(0-6 days)
- wound complications(0-6 days)
- dressing changes(0-6 days)
- pain(0-6 days)
研究者
Jan Bredow
Jan Bredow
University of Cologne