C2654 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Adhered dressing area after wear
研究概览
简要总结
Although, a huge number of acute wounds is treated successfully every year, Health Care Professionals (HCPs) are facing more and more problems when treating skin damages or surgical incisions: The number of patients with fragile and/or sensitive skin is highly increasing. Such patients are having a skin integrity issue, meaning the skin is vulnerable to injury, often damaged, or unable to heal.
The investigational medical devices (IMDs) of the planned clinical evaluation, Leukomed® T skin sensitive and Leukomed® T plus skin sensitive have been developed for treatment of acute wounds on patients with fragile or sensitive skin to provide a reliable but skin-friendly fixation and wound care option.
The primary purpose of this clinical study is the evaluation of clinical performance to stay in place up to seven days and the safety of both dressings. Further, data on wearing comfort, product handling, pain during removal and quality of life are considered as secondary outcomes. The products will be used as part of routine wound care within the scope of their intended purpose without any additional invasive or burdensome examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, women or diverse
- •≥ 65 years of age
- •Patient is mentally and physically able to participate in this study
- •Signed informed consent to participate in this study
- •Fragile skin condition
- •Acute wound (surgical wound or laceration), indicated for treatment with the investigational products for a time period of 7 days
排除标准
- •Infection of the target wound
- •Alcohol or drug addiction
- •Known sensitivity or allergy to any component of the study product
- •Patients who participate in any other clinical study investigating drugs or medical devices
结局指标
主要结局
Adhered dressing area after wear
时间窗: 7 days after dressing application
Percentage of adhered dressing area 7 days after application
次要结局
- Infection(7 days after dressing application)
- Product Evaluation by patient(7 days after dressing application)
- Skin damage(7 days after dressing application)
- Skin reddening(7 days after dressing application)
- Pain assessment(7 days after dressing application)
- Product Evaluation by Health Care Professional(at application day (day 0))
- Skin reactions(after 7 days)