Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Performance of the Debridement Pad
研究概览
简要总结
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.
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
- •Males or females aged 18 years or above.
- •Patients who can understand and give informed consent to take part in the study.
- •Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds
- •Wounds that require debridement due to the presence of slough debris/fibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin.
- •Wounds with both serous crusts and healthy tissue.
- •Minimum of 30% of the wound covered by debris, necrosis or slough.
- •Wound Size > 4cm2
排除标准
- •Patients who are known to be non-compliant with medical treatment
- •Patients who are known to be sensitive to any of the device components such as polyester.
- •Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study.
- •Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
- •Symptoms & signs of systemic and / or spreading wound infection (including erythema and fever).
- •Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area).
- •Subjects who in the view of the investigator might not be suitable for inclusion in the study
研究组 & 干预措施
Intervention
干预措施: Debridement Pad (Device)
结局指标
主要结局
Performance of the Debridement Pad
时间窗: From baseline to immediately after treatment
Performance of the Debridement Pad on Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds. Success will be determined by the following: 1\. Change of wound bed condition from baseline (pre debridement) to assessment immediately after the use of the debridement pad as defined as a. Percentage reduction of wound coverage of visible debris/necrosis/slough from the wound bed at baseline assessment and after procedure.
次要结局
- Safety by adverse events(From baseline to immediately after treatment)
- Time recorded for procedure(From baseline to immediately after treatment)
- Removal of debris(From baseline to immediately after treatment)
- Pain during procedure(From baseline to immediately after treatment)
- Overall clinician satisfaction(From baseline to immediately after treatment)
- Patient tolerability(From baseline to immediately after treatment)
- Device use wet or dry(From baseline to immediately after treatment)