Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.
研究概览
简要总结
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
详细描述
This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •Patient is legally capable
- •Patient has signed written informed consent
- •Presence of one of the following wounds
- •Venous lower leg ulcer
- •Arterial ulcer
- •Diabetic ulcer
- •Pressure ulcer
- •Post-operative wound healing by secondary intention
- •Traumatic wound
- •Surgical wound
- •Burn or scald (grade III: after surgical debridement)
- •Epidermolysis Bullosa
- •Wound area >4cm2
- •The entire wound area can be displayed on one photo from a distance of 25-30 cm
- •Covered with at least 30% debris, necrosis, slough, fibrotic tissue
排除标准
- •Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
- •Pregnancy or breast feeding
- •Patient is illiterate
- •Participation in a interventional clinical trial within the last 14 days and during participation in this study
- •Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
- •severe pain or hyperesthesia in the wound area
- •history of drug or alcohol abuse
- •chronic analgesic use (especially opioids) that could influence baseline pain perception
- •cognitive impairment, which may affect the ability to accurately self-report pain
- •Use of anaesthesia before the debridment procedure
- •presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary
研究组 & 干预措施
Debrisoft Duo
Patients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris.
干预措施: two sided debridement pad (Device)
Debrisoft Pad
Patients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side.
干预措施: one sided debridment pad (Device)
结局指标
主要结局
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.
时间窗: 1 day
Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).
次要结局
- Amount of products(1 day)
- Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator(1 day)
- Rate of device-related adverse events (device safety)(1 day)
- Wound related pain(1 day)
- Patient satisfaction(1 day)
- Change of wound bed condition, defined by the combination of the following parameters:(1 day)
- User satisfaction(1 day)
- Time needed for debridement(1 day)