The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.
研究概览
简要总结
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms
详细描述
Background: Chronic wounds and wound infections can be costly, resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia. In the UK the management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times.
AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a gel when it becomes wet. Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden. Removing these potential barriers to healing may help towards wound progression.
Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume over the treatment 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
- •Provided written informed consent
- •Be over 18 years of age
- •Must have a chronic foot wound greater than 4 weeks in duration
- •Be willing and able to attend the clinic for the required study visits -
排除标准
- •Subjects with a history of sensitivity to any one of the components of the device being studied
- •Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- •Subjects who are currently participating in or have been on a clinical study within the last 4 weeks.
结局指标
主要结局
A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.
时间窗: up to day 28
Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms.
次要结局
- Size of the wound and an indicator of healing(up to day 28)
研究者
Dr Angela Oates
Dr
University of Manchester