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
- 1
- 主要终点
- Minimize the Risk of the Development of Blistering
研究概览
简要总结
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).
详细描述
At the baseline visit:
- Subject demographic details
- Inclusion and exclusion criteria
- Vital signs
- Medical and surgical history
- Skin status at incision site
- Mobilisation (subject mobility, mobilisation in bed and chair)
- Medication
- AE/ADE/ SAE/SADE/DD
- Informed consent
- Randomization
At visit 2:
- Type of surgery
- Length of incision
- Intraoperative antibiotic given
- Length of anesthesia
At each visit from visit 3:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 due to tumor
- •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
研究组 & 干预措施
Mepilex Border®
Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery
干预措施: Mepilex Border® (Device)
Cosmopor steril®
Standard wound dressing at patients after hip-knee or primary spine surgery
干预措施: Cosmopor steril® (Device)
结局指标
主要结局
Minimize the Risk of the Development of Blistering
时间窗: 7 days after surgery
Number of participants without blisters at study visit
次要结局
- Comfort, Comformability, Acceptability of the Dressing(7 days)
- Change From Baseline in Pain on the visual analog scale(7 days)
- the overall cost regarding dressing wear time(7 days)
- Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing(7 days)
研究者
Jan Bredow
Dr.med.
University of Cologne