Post-Marketing Surveillance of Vliwazell® Prowound Dressing

Официальное название

Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Vliwazell® Pro User Satisfaction with Exudate Management [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (8)

• Improvement of wound condition [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Safety evaluation: Incidence of maceration of wound or surrounding skin [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Safety evaluation: Incidence of skin damage due to adhesion of wound dressing [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
• Safety evaluation: Incidence of bursting of wound dressing [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
• Safety evaluation: Compatibility with other wound care products [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
• Patient-reported wound pain intensity measured by NRS-11 [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
• User satisfaction and usability [Срок оценки: From enrollment to the end of treatment at 2 weeks.]
• Patient satisfaction [Срок оценки: From enrollment to the end of treatment at 2 weeks.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Германия · 8 центров

• Wundmanagement — Aachen
• MVZ Hausärzte — Brüggen
• ORGAMed — Dortmund
• Hautklinik — Erlangen
• Krankenhaus Tabea — Hamburg
• WKM Rösner Mönchengladbach — Mönchengladbach
• Gesundheitsmanager, Inh. Christine Bertram — Waidhaus
• WKM Rösner Willich — Willich

Идентификаторы

NCT: NCT07316556 · 2018-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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