A Clinical Study to Compare the Performance of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® Dressing in the Management of Patients With Venous Leg Ulcers Over a 12-week Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 22
- 主要终点
- Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management
研究概览
简要总结
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
详细描述
Post market, multi-centre, randomised, open label, multi-national, prospective study to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
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
- •Venous insufficiency as defined by CEAP Classification of C6
- •One wound amendable to treatment with either AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
- •Wounds that have been present for at least 2 months
- •Reliable and available for follow-up
- •18 years or older
- •Able and willing to provide informed consent
- •Able to tolerate compression therapy for Venus Leg Ulcer
- •Must be able to be compliant with compression therapy
排除标准
- •Known sensitivities or allergies to components of the AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
- •Continued use of petroleum gel/ creams/ oil-based products
- •Active treatment for cancer or completed within the last 3 months
- •Documented severe malnutrition
- •Malignant wounds
- •Systemic infection actively treated with antibiotics
研究组 & 干预措施
AQUACEL® Ag+ Extra™
AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
干预措施: AQUACEL® Ag+ Extra™ (Device)
Cutimed® Sorbact®
Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
干预措施: Cutimed® Sorbact® (Device)
结局指标
主要结局
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management
时间窗: Up to 12 weeks
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
次要结局
- Wound Healing Assessment(Up to 4 weeks)
- Wound Progress Assessment(Up to 4 weeks)
- Wound Change Assessment(Up to 12 weeks)
- Safety Assesment(Up to 12 weeks)