Condition: Acute and Chronic Wounds · Sponsor: Lohmann & Rauscher
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
Uta Brunner · +49 (0) 6732-600 8624 · project@brunner-memmhardt.de
Katerina Kusalova · kusalova@biostatistika.cz
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Wundmanagement | Aachen, Germany | Recruiting |
| MVZ Hausärzte | Brüggen, Germany | Recruiting |
| ORGAMed | Dortmund, Germany | Recruiting |
| Hautklinik | Erlangen, Germany | Recruiting |
| Krankenhaus Tabea | Hamburg, Germany | Recruiting |
| WKM Rösner Mönchengladbach | Mönchengladbach, Germany | Not Yet Recruiting |
| Gesundheitsmanager, Inh. Christine Bertram | Waidhaus, Germany | Recruiting |
| WKM Rösner Willich | Willich, Germany | Not Yet Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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