An Open Randomised Comparative Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- Wear Time
研究概览
简要总结
Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to AQUACEL® in the management of chronic wounds such as venous leg ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects over 18 years, willing and able to provide written informed consent.
- •Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
- •Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1) with duration less than 24 months
- •Subjects whose ulcer is no smaller than 2cms in any one direction
- •Subjects whose ulcer is no greater than 11cm in any one direction (measured by longest length and widest width)
- •Subjects' whose index leg ulcer has a moderate to heavy level of exudate.
- •Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
- •Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study dressings (AQUACEL® Extra™, AQUACEL®, & DuoDERM™ Extra Thin)
- •Subjects whose wounds are considered clinically infected at baseline
- •Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
- •Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
- •Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- •Subjects who have participated in a clinical study within the past month.
研究组 & 干预措施
AQUACEL®
A sterile non-woven sheet of sodium carboxymethylcellulose (NaCMC).
干预措施: AQUACEL® (Device)
AQUACEL® Extra™
A sandwiched construction of two layers of optimally textiled non-woven fabric, stitch-bonded together using Lyocel (Tencel™ regenerated cellulose) yarns.
干预措施: AQUACEL® Extra™ (Device)
结局指标
主要结局
Wear Time
时间窗: 4 weeks
frequency of dressing changes
% of dressings achieving a 7 day wear time
时间窗: 4 weeks
Time to achieve a 7 day wear time
时间窗: 4 weeks
Condition of the peri-ulcer skin
时间窗: 4 weeks
Improvement from baseline in the condition of the peri-ulcer skin
次要结局
未报告次要终点