RecruitingOBSERVATIONAL

Post-Marketing Surveillance of Vliwazell® Prowound Dressing

This study is gathering real-world information on a special wound dressing called Vliwazell® Pro. We want to confirm it’s effective and safe for people with different types of wounds that produce a moderate to large amount of fluid. The study will look at how the dressing affects the wound itself, the skin around it, any smell, and overall healing. We'll also ask patients and healthcare staff if they are happy with how easy the dressing is to use. This helps us understand if Vliwazell® Pro is a good option for treating various acute and ongoing wounds in standard care.

At a glance

Status

Recruiting

Sponsor

Lohmann & Rauscher

Enrolment target

208

Start

11 Mar 2024

Estimated completion

31 Jan 2027

Acute and Chronic Wounds

What is this study about?

Imagine you have a wound that produces a lot of fluid, like a cut that won't heal quickly or a sore that's been there for a while. This study is all about a specific type of dressing called Vliwazell® Pro, which is designed to handle this fluid.

We want to see how well Vliwazell® Pro works in real-life situations. This means we're observing patients in their usual care settings, rather than in a highly controlled research environment. We're interested in whether it helps wounds heal, if it keeps the surrounding skin healthy, and if it reduces any unpleasant smells. We'll also be closely watching for any unexpected effects to make sure it's safe.

The dressing itself is soft and flexible, and it's very good at soaking up wound fluid. It has a special inner layer that spreads the fluid evenly and pulls it into a core, stopping the fluid from sitting on the wound and irritating the skin around it. Because it can absorb so much, you might not need to change the dressing as often, which can be more comfortable and allow the wound to heal undisturbed for longer. There's also a blue outer layer to protect your clothes and bedding. This study helps us understand the true value of Vliwazell® Pro for people with various acute (sudden) and chronic (long-lasting) wounds.

Key takeaways

This study is observing a wound dressing called Vliwazell® Pro.
It's for wounds that produce moderate to a lot of fluid.
The dressing helps manage fluid and may reduce dressing changes.
The study checks both safety and how well it works in real-life use.
It's not for dry wounds or people under 18.
You won't have extra visits beyond your usual care.

Who may be eligible?

To join this study, you need to have certain types of wounds that produce a moderate to large amount of fluid. These could be wounds on your legs or feet, sores from pressure, or wounds after an injury or surgery. It also includes some more specific conditions like skin graft sites or certain types of burns, as long as they are not too deep. If you have a deep wound, Vliwazell® Pro can be used as the top layer over another wound filler.

You must be 18 years old or older and understand what the study involves before you agree to take part. Also, you cannot be pregnant or breastfeeding, or currently involved in another medical study. People who are allergic to any part of the dressing, have very dry wounds, or have specific 'tunnel' wounds where the dressing might expand too much, won't be able to join. Finally, you need to have health insurance or social security to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a wound that produces a moderate to large amount of fluid?
Are you not pregnant or breastfeeding?
Are you able to understand the study and agree to take part?
Are you not allergic to any part of the dressing?
Do you have health insurance or social security?

Answer every question to see your result.

What does participation involve?

As this is a 'post-marketing' study, it means the dressing is already available, and we are observing its use in real-world situations. This means you would receive the Vliwazell® Pro dressing as part of your usual wound care, and healthcare professionals would monitor your wound as they normally would. They would gather information on how your wound is healing, such as the amount of fluid it produces, its appearance, and any changes to the surrounding skin. You would also be asked about your comfort and satisfaction with the dressing. The duration of your participation would depend on your individual wound healing journey, as this study doesn't involve fixed appointments or extra visits beyond your routine care. There are no study medications, as the focus is on the dressing.

Potential risks and benefits

The potential benefits of using Vliwazell® Pro include helping to manage wound fluid, potentially reducing the need for frequent dressing changes, and protecting the skin around the wound. There's also the chance your wound could heal more effectively with good fluid management. As with any medical product, there's a small risk of an allergic reaction to the dressing, though this is rare. If you experience any discomfort or changes, it's important to tell your healthcare team immediately. Remember, you have the right to withdraw from the study at any time without affecting your ongoing medical care.

Locations (8)

Wundmanagement
Verified postcode
Aachen, Germany· Recruiting
MVZ Hausärzte
Verified postcode
Brüggen, Germany· Recruiting
ORGAMed
Verified postcode
Dortmund, Germany· Recruiting
Hautklinik
Verified postcode
Erlangen, Germany· Recruiting
Krankenhaus Tabea
Verified postcode
Hamburg, Germany· Recruiting
WKM Rösner Mönchengladbach
Verified postcode
Mönchengladbach, Germany· Not yet recruiting
Gesundheitsmanager, Inh. Christine Bertram
Verified postcode
Waidhaus, Germany· Recruiting
WKM Rösner Willich
Verified postcode
Willich, Germany· Not yet recruiting

Common questions

What kind of wounds is this dressing for?

It's for wounds that produce a fair amount of fluid, like leg ulcers, pressure sores, or surgical wounds. It's not for dry wounds or very deep, narrow wounds.

Will I have to do extra visits if I join?

No, this study observes the dressing during your usual wound care. There shouldn't be any extra appointments or visits beyond what your doctor already recommends.

Is the dressing safe?

The study aims to confirm its safety and effectiveness in routine use. The main risk is a potential allergic reaction, but this is uncommon.

Can I stop using the dressing if I don't like it?

Yes, you can choose to stop participating in the study at any time, and it won't affect the care you receive for your wound.

Will this dressing protect my clothes?

Yes, it has a blue outer layer specifically designed to help protect your clothing and bedding from wound fluid.

How to find out more

Uta Brunner

project@brunner-memmhardt.de +49 (0) 6732-600 8624 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.