Post Market Clinical Follow up Study to Examine Clinical Performance of the Debridement Pad Cutimed DebriClean
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)
研究概览
简要总结
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
详细描述
60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product.
Per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male or female subjects aged 18 years or older with full legal competence
- •Signed informed consent
- •Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
- •Superficial wound
- •Minimum 30 % of the wound is covered by debris, necrosis or slough
- •Wound size > 4 cm²
排除标准
- •Subjects not willing to participate or to attend the scheduled study visit
- •Known sensitivity or allergy to the product components
- •Severe pain or hyperaesthesia in the wound area
- •Patients who are pregnant or lactating
- •Drug abuse or alcohol abuse
- •Patients who participate in any other clinical study investigating drugs or medical devices
结局指标
主要结局
Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit)
时间窗: assessed immediately before and immediately after the mechanical debridement (within one study visit)
Percentage of wound coverage with debris/necrosis/slough Wound edge cleaned smooth Surrounding skin cleaned e.g. from skin flakes
次要结局
- Wound size after and before wound debridement(assessed immediately before and immediately after the mechanical debridement (within one study visit))
- Adverse device effects(assessed immediately after the debridement procedure)
- Debris/necrosis/slough absorbed by test product(assessed immediately after the mechanical debridement)
- Structural integrity of the test product(assessed immediately after the mechanical debridement)
- Pain during the debridement procedure(assessed immediately after the debridement procedure)
- Time needed for the debridement procedure(Time is measured during the debridement procedure)