A Prospective Single-arm Study Investigating the Safety of Biatain Silicone Sacral While Used as Prevention in Hospital-admitted Patients at Risk of Developing a Pressure Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Number of Adverse Events
研究概览
简要总结
A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.
详细描述
The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.
At daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.
There were no follow-up visits after termination of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1
- •≥18 years of age and has full legal capacity
- •Has given written consent to participate by signing the Informed Consent signature Form
- •Has a Braden score of 6-18 at screening (performed within the last 24 hours)
- •Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence)
排除标准
- •Suspected or actual spinal injury precluding the patient from being turned
- •Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury
- •Trauma to sacrum
- •Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)
- •Pregnancy or breastfeeding
研究组 & 干预措施
Biatain Silicone Sacral Dressing
干预措施: Biatain Silicone Sacral dressing (Device)
结局指标
主要结局
Number of Adverse Events
时间窗: 7 days
Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged)
次要结局
- Number of Device Deficiencies(7 days)