NCT01036438已完成4 期
A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Molnlycke Health Care AB84 个研究点 分布在 4 个国家目标入组 201 人开始时间: 2009年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 84
- 主要终点
- Efficacy Will be Defined as Absolute Wound Size Reduction.
研究概览
简要总结
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
- •A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
- •Subjects with colonised/local infection presenting with three of five following specified signs:
- •pain between dressing changes
- •exuding wounds
- •erythema on peri-wound skin
- •An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
- •Ulcer duration 6 weeks to 1 year
- •In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
- •Both gender with an age ≥ 18 years
- •Signed informed consent
排除标准
- •> 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
- •Infected wounds in need of systemic antibiotic treatment
- •Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- •Previous treatment with silver product 2 weeks prior to inclusion
- •Previous treatment with MepilexAg® on the target ulcer
- •Use of systemic antibiotics for any reason during the previous 7 days
- •Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
- •Subjects with poorly controlled diabetes mellitus i.e. HbA1c >8%
- •Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
- •Known allergy/hypersensitivity to any of the components of the investigation products.
- •Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
- •Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
- •Previously randomised to this investigation.
- •Life expectance of the subject less than 3 months
- •Pregnant or breast-feeding women
研究组 & 干预措施
Mepilex product
Placebo Comparator
干预措施: Mepilex without Ag (Device)
Mepilex Ag
Active Comparator
干预措施: Mepilex Ag (Device)
结局指标
主要结局
Efficacy Will be Defined as Absolute Wound Size Reduction.
时间窗: 8 weeks
Efficacy will be defined as absolute wound size reduction.
次要结局
- Change in Inflammatory Signs(4 weeks)
研究者
研究点 (84)
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