An Open Non-controlled Post-marketing Investigation Evaluating the Experience of Using a Self- Adherent Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice
研究概览
简要总结
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well
详细描述
At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn.
At each visit the following variables will be collected where applicable:
-
Investigator's/Nurse evaluation of
-
Overall experience of the dressing
-
Ability of dressing to stay in place (not at baseline)
-
Conformability of the dressing
-
Handling at application
-
Ease of removal of the dressing (not at baseline)
-
Subject evaluation of
-
Overall experience of the dressing
-
Comfort of the dressing
-
Conformability of the dressing
-
Pain before, during and after removal of dressing according to VAS
-
Status of skin
-
Burn status: width x length, exudate details and signs of inflammation/infection
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 small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*
- •Male or female, 18 years and above, both in- and out-patient subjects
- •Signed Informed Consent Form
排除标准
- •Wound size equal to or above 9.5x15cm for the selected burn for the investigation
- •Pregnant and/or breastfeeding women
- •Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
- •Subjects with known sensitivity to silver or any other contents of the dressing
- •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
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice
时间窗: 3 weeks
burns healed
次要结局
- Pain(3 weeks)
- Evaluate the Comfort(3 weeks)