Acute and Chronic WoundsVliwazellNCT07316556
Post-Marketing Surveillance of Vliwazell® Prowound Dressing
An observational study of Acute and Chronic Wounds, run by Lohmann & Rauscher at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute and Chronic Wounds
- How many people
- 208 participants
- Where
- 8 sitesGermany
- Study dates
- 11 Mar 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Patient is able to understand and provide information
- Patient has signed the written Informed Consent Form
Who cannot join
- 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
- Patients participating in another clinical trial at the time of inclusion
- Patient not covered by health insurance/social security
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Katerina Kusalova contact
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Wundmanagement
Aachen
Alessandra Hoffmann, +49 241- 99089994, info@wundmanagement-aachen.de
- Recruiting
MVZ Hausärzte
Brüggen
Johann Heinrich Arens, Dr., +49 2163 5749 100, info@brueggen.mvzsn.de
- Recruiting
ORGAMed
Dortmund
Carsten Hampel-Kalthoff, Dr., + 49 231 - 936970, info@orgamed-dortmund.de
- Recruiting
Hautklinik
Erlangen
Cornelia Erfurt-Berge, Dr., +49 9131 85-35000, hautklinik@uk-erlangen.de
- Recruiting
Krankenhaus Tabea
Hamburg
Stefania Gerontopoulou, Dr, +49 40 86692-0, hauptempfang@tabea-krankenhaus.de
- Not yet recruiting
WKM Rösner Mönchengladbach
Mönchengladbach
Frederike Rösner, 02161 - 47745 45, roesner@wkmonline.de
- Recruiting
Gesundheitsmanager, Inh. Christine Bertram
Waidhaus
Christine Bertram, +49 171 - 33 73 027, christine.bertram@gesundheits-manager.eu
- Not yet recruiting
WKM Rösner Willich
Willich
Frederike Rösner, 02154 - 88778 44, roesner@wkmonline.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute and Chronic Wounds
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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".
Measured: 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".
Measured: From enrollment to the end of treatment at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start11 Mar 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Eberlain, Dr, Principal investigator, Lohmann & Rauscher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316556
- Sponsor's protocol ID
- 2018-01
- Acronym
- Vliwazell
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy considerations and the nature of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing
- ClinicalTrials.gov ID
- NCT07316556
- Acronym / sponsor ID
- Vliwazell / 2018-01
- Conditions
- Acute and Chronic Wounds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:
- As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used 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
Key exclusion criteria (8 listed)
- Age < 18 years
- Patient with contraindication:
- Pregnant or lactating women
- Patients participating in another clinical trial at the time of inclusion
- Patient not covered by health insurance/social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vliwazell® Pro User Satisfaction with Exudate Management
Time frame: From enrollment to the end of treatment at 2 weeks
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."
8 secondary outcomes
Improvement of wound condition
Time frame: From enrollment to the end of treatment at 2 weeks
Safety evaluation: Incidence of maceration of wound or surrounding skin
Time frame: From enrollment to the end of treatment at 2 weeks
Safety evaluation: Incidence of skin damage due to adhesion of wound dressing
Time frame: From enrollment to the end of treatment at 2 weeks.
Safety evaluation: Incidence of bursting of wound dressing
Time frame: From enrollment to the end of treatment at 2 weeks.
Safety evaluation: Compatibility with other wound care products
Time frame: From enrollment to the end of treatment at 2 weeks.
Patient-reported wound pain intensity measured by NRS-11
Time frame: From enrollment to the end of treatment at 2 weeks.
User satisfaction and usability
Time frame: From enrollment to the end of treatment at 2 weeks.
Patient satisfaction
Time frame: From enrollment to the end of treatment at 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy considerations and the nature of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katerina Kusalova contact
Thomas Eberlain, Dr principal investigator
Lohmann & Rauscher
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute and Chronic Wounds, run by Lohmann & Rauscher at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uta Brunner (+49 (0) 6732-600 8624, project@brunner-memmhardt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vliwazell® Pro User Satisfaction with Exudate Management (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.