Actively Recruiting
Post-Marketing Surveillance of Vliwazell® Prowound Dressing
Led by Lohmann & Rauscher · Updated on 2026-01-05
208
Participants Needed
8
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Marketing Surveillance of Vliwazell® Prowound Dressing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Wound types according to instructions for use, including superficial acute and chronic wounds with moderate to very high exudate such as 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 second degree burns, and lymphatic wounds
- Use as a secondary dressing on laparotomy wounds and fistulas or for deep wounds 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
You will not qualify if you...
- Age under 18 years
- Known allergy or hypersensitivity to any product components
- Not for use in tunnel-forming wound pockets
- Not for use on dry wounds
- Pregnant or lactating women
- Participation in another clinical trial at time of inclusion
- Patient not covered by health insurance or social security
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Wundmanagement
Aachen, Germany
Actively Recruiting
2
MVZ Hausärzte
Brüggen, Germany
Actively Recruiting
3
ORGAMed
Dortmund, Germany
Actively Recruiting
4
Hautklinik
Erlangen, Germany
Actively Recruiting
5
Krankenhaus Tabea
Hamburg, Germany
Actively Recruiting
6
WKM Rösner Mönchengladbach
Mönchengladbach, Germany
Not Yet Recruiting
7
Gesundheitsmanager, Inh. Christine Bertram
Waidhaus, Germany
Actively Recruiting
8
WKM Rösner Willich
Willich, Germany
Not Yet Recruiting
Research Team
U
Uta Brunner
CONTACT
K
Katerina Kusalova
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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