An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Changes in Signs and Symptoms of Local Infection
研究概览
简要总结
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
详细描述
Approximately 25-30 subjects from two to three centers will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects to be included were to suffer from a DFU and being in need of anti-microbial wound dressing.
Dressing changes were to performed according to the local clinical routine (usually 3 times/week), evaluated during a total treatment period of maximum 4 weeks including weekly visits when assessments were being done. A record (dressing log) for Mepilex Transfer Ag and outer layers were to be filled in at every dressing change.
Photos taken directly upon dressing removal and after cleansing /debridement were to be collected to visually follow the ulcers status.
At each visit the investigators/nurse and subjects opinion (using an evaluation form) were to be asked for questions considering the use of Mepilex Transfer Ag. Pain before, during and after removal will be assessed.
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
- •Both gender>=18 years old
- •Subjects with type 1 or 2 diabetes mellitus
- •Two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour)
- •Ulcer localization; below the ankle
- •Signed Informed Consent
排除标准
- •Known allergy/hypersensitivity to the dressing
- •Treated with other Silver dressing on the ulcer target within 1 week prior to this investigation
- •Subjects who will have problems following the clinical investigation plan
- •Subjects enrolled in the investigation already
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days. Subjects participating in a clinical sample investigation might be enrolled in the investigation.
研究组 & 干预措施
Mepilex Transfer Ag
Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time.
干预措施: Mepilex Transfer Ag (Device)
结局指标
主要结局
Changes in Signs and Symptoms of Local Infection
时间窗: 4 weeks
Evaluation of signs of infection (exudate) from baseline
次要结局
- Levels of Pain in Connection to Dressing Changes.(4 weeks)