NCT01427491已完成3 期
A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Microbial load reduction
研究概览
简要总结
The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.
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
- •Aged 18 years or over
- •Willing and able to provide written informed consent
- •Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate
- •Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
排除标准
- •Known skin sensitivity to any component of the products being tested
- •Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion
- •Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)
- •Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- •Participated in a clinical study within the past 30 days
结局指标
主要结局
Microbial load reduction
时间窗: Days 1 and 14
The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.
次要结局
- clinical evolution of the wound (presence of each of the selected clinical signs)(Days 1, 3, 7, 14)
- Occurrence of adverse events(Day 1-14)
研究者
研究点 (6)
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