Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)
研究概览
简要总结
Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds
详细描述
National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.
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
- •Acute wound: traumatic wound (dermabrasion, skin tears, other), small burns 1st and 2nd degree requiring the use of dressings
- •Acute wound size between 3 cm² and 24 cm² (wound could be covered by 2 investigational products maximum)
- •Wound whose duration is ≤ 3 days
- •Both gender with an age ≥ 18 years
- •Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
- •Subject able to follow the protocol
排除标准
- •Chronic and acute surgical wound
- •Infected, moderately to strongly exudative and haemorrhagic wound
- •Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, etc.) which as judged by the investigator could interfere with the pain assessment
- •Known allergy/hypersensitivity to any of the components of the investigational products
- •Participation in other clinical investigation within one month prior to start of investigation
- •Pregnant or breast-feeding women
- •Person protected by a legal regime (tutorship or guardianship)
- •Patients unable to manifest an oral consent to participate (e.g. dementia) or to understand the use of the VAS (visual analogue scale) tool
- •Patient not covered by health insurance/social security
研究组 & 干预措施
Lomatuell Pro
Lomatuell Pro® is a wound contact layer consisting of wide-meshed tulle, impregnated with a polymer matrix, which form a gel on contact with wound exudate to facilitate moist wound healing.
干预措施: Lomatuell Pro (Device)
UrgoTul
UrgoTul® is a flexible contact layer with TLC (Technology Lipido-Colloid) healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.
干预措施: UrgoTul (Device)
结局指标
主要结局
Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)
时间窗: At Visit 2 (Day 3 ± 2 days)
To evaluate the main study objective, patients were asked to assess the pain they felt during the first dressing removal (D3±2 days) with a means of visual analog scale (VAS), a 100 mm straight line ranging from 0 to 100, where "0" refers to "no pain" and "100" to the "worst pain imaginable". The VAS score was directly measured by the investigator with a scale in millimetres and the number was entered in the patient's case report from (CRF).
次要结局
- Complete Healing(At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized))