Vliwazell Pro wound dressing follow-up for real-world use

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

This follow-up will see if Vliwazell Pro safely controls wound fluid and protects the skin around acute and chronic wounds in adults who need a high-absorbency dressing.

Quick facts

• Study type: Observational
• Enrollment: 208 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lohmann & Rauscher (Industry-sponsored)
• Locations: 8 sites (Aachen and 7 other locations)
• Trial ID: NCT07316556 on ClinicalTrials.gov

What this trial studies

This post-marketing, observational follow-up collects real-world data on the performance and safety of the Vliwazell Pro superabsorbent dressing during routine wound care. Clinicians will record wound characteristics such as exudate level, odor, and condition of the surrounding skin, along with any device-related adverse events. The study also gathers patient and healthcare provider satisfaction and documents dressing change frequency in everyday practice. No experimental interventions are assigned; the product is used according to its intended indications and standard care.

Who should consider this trial

Good fit: Adults (18+) with superficial acute or chronic wounds that produce moderate to very high amounts of exudate—such as venous, arterial, diabetic, pressure, post‑operative, oncologic wounds, or donor sites—who can give informed consent are ideal candidates.

Not a fit: Patients under 18, those with a known allergy to any dressing component, or patients with tunnel-forming wound pockets (a contraindication) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the dressing could reduce the need for frequent changes, protect surrounding skin from maceration, and make wound care more convenient and comfortable for patients.

How similar studies have performed: Similar superabsorbent dressings have shown benefit in reducing maceration and dressing-change frequency in prior real-world and clinical reports, though product-specific post-market data for Vliwazell Pro are limited.

Eligibility criteria

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

Where this trial is running

Aachen and 7 other locations

• 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)

Study contacts

• Principal investigator: Thomas Eberlain, Dr — Lohmann & Rauscher
• Study coordinator: Uta Brunner

Conditions Acute and Chronic Wounds