Post-market Surveillance Study to Confirm the Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Evaluation of Wound progression following 6 weeks (Efficacy)
研究概览
简要总结
Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.
详细描述
Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites.
The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management.
This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate).
It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses.
The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.
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 provide a negative pregnancy test at screening).
- •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 or Donor site wounds that are infected, or are at high risk of infection (in the opinion of the Investigator), that are moderate to heavy levels of exudate.
- •Pressure ulcers that are moderate to high exudate, typically Category 3 and
- •Only one primary wound may be treated per patient for the study.
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;
- •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 enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
结局指标
主要结局
Evaluation of Wound progression following 6 weeks (Efficacy)
时间窗: 6 weeks
wound progression from baseline to end of follow-up. In order to be considered successful in wound progression, at least one of the following must occur in the change from baseline to the end of follow-up: * Increase in % of wound granulation tissue * Decrease in wound size (volume, area, or depth) or wound closure * Decrease in devitalized tissue In addition to the following: • Reduction or no signs or symptoms of clinical infection.
Subject incidence of any treatment-related adverse events during follow-up period - 6 weeks (Safety)
时间窗: 6 weeks
The primary safety analysis will be the calculation of the subject incidence of any treatment-related adverse events between treatment initiation and the end of follow-up for each patient.
次要结局
- Percent change in wound size(6 weeks)
- Percent change in devitalized tissue(6 weeks)
- Change in wound odour(6 weeks)
- Ease of use assessment using Likert-type scale(6 weeks)
- The number of components of the primary efficacy endpoint experienced by each subject(6 weeks)
- Change in wound granulation tissue(6 weeks)
- Rates of individual components of wound progression (primary efficacy endpoint)(6 weeks)
- Pain assessment(6 weeks)