Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 14
- 主要终点
- Effectiveness of the Silver II Non-Woven Dressing
研究概览
简要总结
Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds
详细描述
The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of Pressure ulcers, Leg ulcers, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and 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 re-infection 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
- •Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
- •Patients who are able to understand and give informed consent to take part in the study.
- •Have one or more of the following: Pressure ulcer, Leg ulcer, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate.
- •For Partial Thickness Second Degree Burns that require grafting - only those grafts with single thickness mesh grafts that have X % epithelialization will be enrolled [Note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the Silver II Non Woven Dressing study is likely to be performed].
排除标准
- •Patients who are known to be non-compliant with medical treatment,
- •Patients who are known to be sensitive to any of the device components
- •Subject is pregnant or actively breastfeeding;
- •Subject has a known sensitivity to Silver;
- •Life expectancy of <6 months;
- •Maximum burn area of > 20% total body area. Using the rule of nines assessment tool. [Note: criteria to be confirmed once sites/countries are chosen]
- •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;
结局指标
主要结局
Effectiveness of the Silver II Non-Woven Dressing
时间窗: 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.
Effectiveness (performance) of the Silver II Non-Woven Dressing 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.
次要结局
- User satisfaction with the Silver II Non-Woven Dressing.(immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.)