Post Market Surveillance Study to Confirm the Safety and Performance of the Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 6
- 主要终点
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing
研究概览
简要总结
Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.
详细描述
The design of the study is an open label, multicentre, single arm trial with subjects with moderate to heavily exuding chronic and acute wounds consisting of pressure ulcers, leg ulcers, diabetic leg and foot ulcers, surgical wounds first degree superficial and partial thickness burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without refection during 6- week treatment and follow up period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a pressure ulcer, leg ulcer, diabetic leg and foot ulcer, surgical wound, first degree superficial burns or partial thickness second degree burns that are infected following assessment of signs and symptoms of infection with moderate to heavy levels of exudate.
- •Have wounds at high risk of infection.
- •Males or females, age 18 years or above.
- •Subjects who are able to understand and give informed consent to take part in the study.
排除标准
- •Subjects who are known to be non compliant with medical treatment.
- •Subjects who are known to be sensitive to any of the device components, known sensitivity to PHMB.
- •Subject is pregnant or actively breastfeeding.
- •Subject has any significant or unstable medical or psychiatric condition, that in the opinion of the investigator, would interfere with his/her ability to participate in the study.
- •Subject is currently in another clinical study.
- •Patients who have a current illness or condition, or who have had an illness in the last 30 days which in the opinion of the investigator may interfere with wound healing (e.g. carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse).
- •Life expectancy of <6 months.
- •Maximum burn area of >20% total body area in adults.
结局指标
主要结局
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing
时间窗: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Effectiveness (performance) of the ActivHeal Silicone PHMB will be evaluated for efficacy success according to the following success criteria: Reduction in signs and symptoms of infection from baseline as defined as * The change from the Investigator's opinion of infection being present to no longer being present, or * If the Investigator determines infection is still present there is improvement in severity of at least two. No worsening of any signs/ symptoms of infection at 6 weeks or if infection resolved prior to 6 weeks, that no new evidence of infection occurred during the 6 week treatment follow up.
次要结局
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain at dressing removal.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of wound progression(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of peri wound skin.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of dressing removal.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)
- Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of repositioning.(Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)