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Post-Marketing Surveillance of Vliwazell® Prowound Dressing

Recruitingn/aAges 18 Years - anyAllLohmann & Rauscher
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Wound according to indication mentioned in the instructions for use: 1. 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 2. As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler 3. Patient has full legal capacity 4. Patient is able to understand and provide information 5. Patient has signed the written Informed Consent Form Exclusion Criteria: 1. Age \< 18 years 2. 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. 3. Pregnant or lactating women 4. Patients participating in another clinical trial at the time of inclusion 5. Patient not covered by health insurance/social security
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What it tests

  • Not listed
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Where

8 sites
Wundmanagement
Aachen, Germany
MVZ Hausärzte
Brüggen, Germany
ORGAMed
Dortmund, Germany
Hautklinik
Erlangen, Germany
Krankenhaus Tabea
Hamburg, Germany
WKM Rösner Mönchengladbach
Mönchengladbach, Germany
Gesundheitsmanager, Inh. Christine Bertram
Waidhaus, Germany
WKM Rösner Willich
Willich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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