Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 8
- 主要终点
- Vliwazell® Pro User Satisfaction with Exudate Management
研究概览
简要总结
This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended purpose and certified indications during routine use, and to gather additional safety data. The study will examine how the use of the dressing affects the condition of the skin surrounding the wound, the wound status in terms of exudate, wound odor, and other parameters. Furthermore, the satisfaction of healthcare providers and patients with the application of the dressing will be assessed.
详细描述
Vliwazell® Pro is a flexible and soft superabsorbent wound dressing designed for acute and chronic wounds with moderate to very high levels of exudate (wound fluid). The inner non-woven layer helps evenly distribute the exudate and rapidly channel it into the absorbent core. Excess wound fluid is retained in this layer, protecting the wound and surrounding tissue from maceration.
Vliwazell® Pro has high absorbent capacity and reduces the need for frequent dressing changes due to saturation, allowing the wound to remain undisturbed for longer periods. The outer layer is covered with a blue non-woven fabric that shields the patient's clothing and bed linen.
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
- •Wound according to indication mentioned in the instructions for use:
- •Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:
- •arterial and venous ulcers
- •diabetic ulcers
- •pressure ulcers
- •post-traumatic wounds
- •post-operative wounds healing by secondary intention
- •skin graft donor sites
- •oncological wounds
- •ulcerating tumors
- •wounds at risk of infection
- •superficial 2nd degree burns
- •lymphatic wounds
- •As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler
- •Patient has full legal capacity
- •Patient is able to understand and provide information
- •Patient has signed the written Informed Consent Form
排除标准
- •Age < 18 years
- •Patient with contraindication:
- •Known allergy and/or hypersensitivity to any of the product components.
- •Not for use in tunnel-forming wound pockets, as the product may expand considerably with the absorption of wound exudate.
- •Not for use on dry wounds.
- •Pregnant or lactating women
- •Patients participating in another clinical trial at the time of inclusion
- •Patient not covered by health insurance/social security
结局指标
主要结局
Vliwazell® Pro User Satisfaction with Exudate Management
时间窗: From enrollment to the end of treatment at 2 weeks
The primary objective of this PMCF study is to assess the user satisfaction with exudate management during the use of Vliwazell® Pro. The primary performance parameter is defined as the proportion of users reporting a degree of satisfaction with exudate management after two weeks of treatment that is equal to or better than 4 ("acceptable"). Exudate management is assessed using a six-point Likert scale, ranging from excellent (1), very good (2), good (3), acceptable (4), poor (5), to insufficient (6). After two weeks of treatment, users will be asked to rate the exudate management using the six-level Likert scale. Treatment success is considered achieved when the mean score is equal to or better than "acceptable."
次要结局
- Improvement of wound condition(From enrollment to the end of treatment at 2 weeks)
- Safety evaluation: Incidence of maceration of wound or surrounding skin(From enrollment to the end of treatment at 2 weeks)
- Safety evaluation: Incidence of skin damage due to adhesion of wound dressing(From enrollment to the end of treatment at 2 weeks.)
- Safety evaluation: Incidence of bursting of wound dressing(From enrollment to the end of treatment at 2 weeks.)
- Safety evaluation: Compatibility with other wound care products(From enrollment to the end of treatment at 2 weeks.)
- Patient-reported wound pain intensity measured by NRS-11(From enrollment to the end of treatment at 2 weeks.)
- User satisfaction and usability(From enrollment to the end of treatment at 2 weeks.)
- Patient satisfaction(From enrollment to the end of treatment at 2 weeks.)