NCT02167815已完成不适用
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
Molnlycke Health Care AB5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Changes From Baseline in Condition of the Peri Wound Skin
研究概览
简要总结
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 Leg Ulcer
- •Exuding wound
- •Wound surface covered with sloughy tissue* (before debridement)
- •Wound size ≥ 6 cm2
- •In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
- •Wound suitable for treatment with the relevant primary dressing**
- •Male or female, 18 years of age and above
- •Signed Informed Consent
- •Sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed ** Mepilex XT in the intervention group. Standard care in the observation group
排除标准
- •More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area
- •Wound cavity and/or fistula
- •Full thickness burns
- •Exposed tendons and/or fascia
- •Bleeding wounds
- •Malignant or fungating wounds
- •Wound age > 12 months
- •Use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
- •Untreated limb ischemia (according to investigator's judgement) at the time of inclusion
- •Subject not suitable for the investigation according to the investigator's judgement
- •Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- •Known allergy/hypersensitivity to any of the components of the primary dressing
结局指标
主要结局
Changes From Baseline in Condition of the Peri Wound Skin
时间窗: 16 weeks
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
次要结局
- Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.(16 weeks)
- Pain Scores on the Visual Analog Scale(16 weeks)
- Users Feedback After Handling or Use as a Measure of Performance.(16 weeks)
研究者
研究点 (5)
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