Post-Marketing Surveillance of Vliwazell® Prowound Dressing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute and Chronic Wounds. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing
Overview
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.
Primary outcome measures
- Vliwazell® Pro User Satisfaction with Exudate Management [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (8)
- 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.]
Eligibility criteria
Inclusion criteria
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
- Patient is able to understand and provide information
- Patient has signed the written Informed Consent Form
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 8 centers
- Wundmanagement — Aachen
- MVZ Hausärzte — Brüggen
- ORGAMed — Dortmund
- Hautklinik — Erlangen
- Krankenhaus Tabea — Hamburg
- WKM Rösner Mönchengladbach — Mönchengladbach
- Gesundheitsmanager, Inh. Christine Bertram — Waidhaus
- WKM Rösner Willich — Willich
Identifiers
NCT: NCT07316556 · 2018-01