Post-Marketing Surveillance of Vliwazell® Prowound Dressing (Vliwazell)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute and Chronic Wounds

Detailed Description

Vliwazell® Pro is a flexible and soft superabsorbent wound dressing designed for acute and chronic wounds with moderate to very high levels of exudate (wound fluid). The inner non-woven layer helps evenly distribute the exudate and rapidly channel it into the absorbent core. Excess wound fluid is retained in this layer, protecting the wound and surrounding tissue from maceration.

Vliwazell® Pro has high absorbent capacity and reduces the need for frequent dressing changes due to saturation, allowing the wound to remain undisturbed for longer periods. The outer layer is covered with a blue non-woven fabric that shields the patient's clothing and bed linen.

• Study Type: Observational
• Enrollment (Estimated): 208

Contacts and Locations

• Study Contact: Name: Uta Brunner; Phone Number: +49 (0) 6732-600 8624; Email: project@brunner-memmhardt.de
• Study Contact Backup: Name: Katerina Kusalova; Email: kusalova@biostatistika.cz

Study Locations

• Germany
  • Aachen, Germany
    • Recruiting
    • Wundmanagement
    • Contact: Alessandra Hoffmann; Phone Number: +49 241- 99089994; Email: info@wundmanagement-aachen.de
  • Brüggen, Germany
    • Recruiting
    • MVZ Hausärzte
    • Contact: Johann Heinrich Arens, Dr.; Phone Number: +49 2163 5749 100; Email: info@brueggen.mvzsn.de
  • Dortmund, Germany
    • Recruiting
    • ORGAMed
    • Contact: Carsten Hampel-Kalthoff, Dr.; Phone Number: + 49 231 - 936970; Email: info@orgamed-dortmund.de
  • Erlangen, Germany
    • Recruiting
    • Hautklinik
    • Contact: Cornelia Erfurt-Berge, Dr.; Phone Number: +49 9131 85-35000; Email: hautklinik@uk-erlangen.de
  • Hamburg, Germany
    • Recruiting
    • Krankenhaus Tabea
    • Contact: Stefania Gerontopoulou, Dr; Phone Number: +49 40 86692-0; Email: hauptempfang@tabea-krankenhaus.de
  • Mönchengladbach, Germany
    • Not yet recruiting
    • WKM Rösner Mönchengladbach
    • Contact: Frederike Rösner; Phone Number: 02161 - 47745 45; Email: roesner@wkmonline.de
  • Waidhaus, Germany
    • Recruiting
    • Gesundheitsmanager, Inh. Christine Bertram
    • Contact: Christine Bertram; Phone Number: +49 171 - 33 73 027; Email: christine.bertram@gesundheits-manager.eu
  • Willich, Germany
    • Not yet recruiting
    • WKM Rösner Willich
    • Contact: Frederike Rösner; Phone Number: 02154 - 88778 44; Email: roesner@wkmonline.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of wound condition	One secondary endpoint is the improvement of the wound condition which is measured via a six-level scale: Excellent (1), very good (2), good (3), acceptable (4), poor (5), and insufficient (6). During the termination visit, after two weeks of treatment with Vliwazell® Pro more than 50% of the users should rate the improvement of the wound condition as "acceptable" or better.	From enrollment to the end of treatment at 2 weeks
Safety evaluation: Incidence of maceration of wound or surrounding skin	Monitoring of deterioration of macerated wound surrounding skin or new development of maceration. Monitoring of deterioration of macerated wound surrounding skin or new development of maceration.Maceration will be monitored via adverse event reporting. The assumption is to have less than one third (<33%; in terms of all patients) adverse events with product relationship (excluding user errors) assignable to the event maceration within the course of the study. Adverse events are collected via case report form AE log. AEs meeting criteria for seriousness are reported via SAE case report form and have to be reported to sponsor immediately	From enrollment to the end of treatment at 2 weeks
Safety evaluation: Incidence of skin damage due to adhesion of wound dressing	Monitoring of adverse events related to damage of surrounding skin caused by dressing adhesion. Allergic reactions excluded.The assumption is to have less than one third (<33%; in terms of all patients) adverse events with product relationship (excluding user errors) assignable to a damage of the skin surrounding the wound.	From enrollment to the end of treatment at 2 weeks.
Safety evaluation: Incidence of bursting of wound dressing	Safety parameters as low bursting (adverse device effect: bursting of wound dressing) is monitored by the adverse event reporting. The assumption is that no more than 15% (in terms of all patients) adverse events with product relationship assignable to the event bursting within the course of the study.	From enrollment to the end of treatment at 2 weeks.
Safety evaluation: Compatibility with other wound care products	Monitoring of adverse events related to use in combination with wound irrigation solutions, primary/secondary dressings, wound fillers, or retention materials.The acceptance criterion for the requirement compatibility is no more than 15% adverse events with product relationship.	From enrollment to the end of treatment at 2 weeks.
Patient-reported wound pain intensity measured by NRS-11	The pain felt by the patient regarding the wound and treatment of the wound is measured via the NRS-11 score. For this, the patient is asked to rate his/her level of pain on a scale from 0 (no pain) to 10 (severe pain). Two data measurements (question to the patient) are done directly before and after the treatment with Vliwazell® Pro at the visit 1/baseline visit. Last data measurements are done after the two weeks of treatment with Vliwazell® Pro at the visit 2 / termination visit	From enrollment to the end of treatment at 2 weeks.
User satisfaction and usability	Secondary endpoint for the user satisfaction (Visit 1): Users will be asked at Visit 1 if the selection of sizes for the wound dressing with 10 x 10cm, 10 x 20cm, 15 x 20cm 20 x 25cm and 20 x 40cm is satisfying their needs in daily practice. This parameter is measured on a Two-Point Scale (yes/no) and the assumption (it will not be statistically tested) is that ≥50% for the answer "yes" (for each feature). At termination visit, users will be asked to assess predefined parameters related to dressing performance and usability. The assessment will be conducted using a six-level agreement scale:,These are measured via a six-level scale: 1- I totally agree, 2- I agree,3- Neither agree nor reject, 4- I disagree, 5-I totally disagree. The assumption (not statistically tested) is that as ≥50% answer: "I totally agree" or "I agree".	From enrollment to the end of treatment at 2 weeks.
Patient satisfaction	The patient satisfaction will be collected by a quality of life (QoL) questionnaire typical for wounds. The questionnaire is asked for on initial and closed visits. On closed visit additional questions are included regarding the patient satisfaction. The patients will be asked if they think that Vliwazell® Pro is comfortable for them while wearing and whether they think that the wound dressing has a high wearing comfort. Additionally, they will be asked if clothing and bed linen are protected from soaking and if they feel protected from that by that the wound dressing. These parameters are measured via a six-level scale: 1- I totally agree, 2- I agree,3- Neither agree nor reject,4- I disagree, 5-I totally disagree. The assumption for each question is that ≥50% will answer: "I totally agree" or "I agree".	From enrollment to the end of treatment at 2 weeks.

Collaborators and Investigators

• Sponsor: Lohmann & Rauscher
• Investigators: Principal Investigator: Thomas Eberlain, Dr, Lohmann & Rauscher

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to privacy considerations and the nature of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No