Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Wound Are at Baseline
研究概览
简要总结
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.
详细描述
The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator
- •Male or female, 18 years and above, both in- and out-patients
- •Signed Informed Consent Form
排除标准
- •Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
- •Subject not expected to follow the investigation procedures
- •TBSA > 10% (partial thickness burns only)
- •HbA1C value > 7.
- •(To be measured if BMI > 30)
- •Pregnant and breastfeeding women
- •Pressure ulcers deeper than stage 3
- •Deep pressure ulcers in need of a filler
- •Subjects with known sensitivity to silver or any other dressing materials
- •Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging
- •Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
Wound Are at Baseline
时间窗: Baseline
Wound Area at Visit 2
时间窗: After one week
At each visit the wound length and width is measured and calculated in cm2.
次要结局
未报告次要终点