Post-Marketing Surveillance of Vliwazell® Prowound Dressing

NCT ID: NCT07316556

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute and Chronic Wounds

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lohmann & Rauscher

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Eberlain, Dr

Role: PRINCIPAL_INVESTIGATOR

Lohmann & Rauscher

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wundmanagement

Aachen, , Germany

Site Status RECRUITING

MVZ Hausärzte

Brüggen, , Germany

Site Status RECRUITING

ORGAMed

Dortmund, , Germany

Site Status RECRUITING

Hautklinik

Erlangen, , Germany

Site Status RECRUITING

Krankenhaus Tabea

Hamburg, , Germany

Site Status RECRUITING

WKM Rösner Mönchengladbach

Mönchengladbach, , Germany

Site Status NOT_YET_RECRUITING

Gesundheitsmanager, Inh. Christine Bertram

Waidhaus, , Germany

Site Status RECRUITING

WKM Rösner Willich

Willich, , Germany

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Uta Brunner

Role: CONTACT

+49 (0) 6732-600 8624

Katerina Kusalova

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alessandra Hoffmann

Role: primary

+49 241- 99089994

Johann Heinrich Arens, Dr.

Role: primary

+49 2163 5749 100

Carsten Hampel-Kalthoff, Dr.

Role: primary

+ 49 231 - 936970

Cornelia Erfurt-Berge, Dr.

Role: primary

+49 9131 85-35000

Stefania Gerontopoulou, Dr

Role: primary

+49 40 86692-0

Frederike Rösner

Role: primary

02161 - 47745 45

Christine Bertram

Role: primary

+49 171 - 33 73 027

Frederike Rösner

Role: primary

02154 - 88778 44

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.