Post-Marketing Surveillance of Vliwazell® Prowound Dressing

NCT07316556 | Recruiting

• 1 other identifier: 2018-01
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 8

Brief Summary

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

Acute and Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Vliwazell® Pro User Satisfaction with Exudate Management

  The primary objective of this PMCF study is to assess the user satisfaction with exudate management during the use of Vliwazell® Pro. The primary performance parameter is defined as the proportion of users reporting a degree of satisfaction with exudate management after two weeks of treatment that is equal to or better than 4 ("acceptable"). Exudate management is assessed using a six-point Likert scale, ranging from excellent (1), very good (2), good (3), acceptable (4), poor (5), to insufficient (6). After two weeks of treatment, users will be asked to rate the exudate management using the six-level Likert scale. Treatment success is considered achieved when the mean score is equal to or better than "acceptable."

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (8)

• Improvement of wound condition

  From enrollment to the end of treatment at 2 weeks

• Safety evaluation: Incidence of maceration of wound or surrounding skin

  From enrollment to the end of treatment at 2 weeks

• Safety evaluation: Incidence of skin damage due to adhesion of wound dressing

  From enrollment to the end of treatment at 2 weeks.

• Safety evaluation: Incidence of bursting of wound dressing

  From enrollment to the end of treatment at 2 weeks.

• Safety evaluation: Compatibility with other wound care products

  From enrollment to the end of treatment at 2 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators should enroll patients out of their normal patient pool. Exceptions are vulnerable patients like pregnant or lactating women, patients under 18 years or patient without full legal capacity.

You may qualify if:

• Wound according to indication mentioned in the instructions for use:
• 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
• As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler
• Patient has full legal capacity

You may not qualify if:

• Age \< 18 years
• 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.
• Pregnant or lactating women
• Patient not covered by health insurance/social security

Sponsors & Collaborators

• Lohmann & Rauscher: lead

Study Sites (8)

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 Officials

• Thomas Eberlain, Dr

  Lohmann & Rauscher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uta Brunner

CONTACT

+49 (0) 6732-600 8624; project@brunner-memmhardt.de

Katerina Kusalova

CONTACT

kusalova@biostatistika.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 5, 2026
• Study Start: March 11, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)