RecruitingNCT07316556

Post-Marketing Surveillance of Vliwazell® Prowound Dressing

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

Sponsor

Lohmann & Rauscher

Enrollment

208 participants

Start Date

Mar 11, 2024

Study Type

OBSERVATIONAL

Conditions

Acute and Chronic Wounds

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria17

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 Criteria8

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

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Locations(8)

Wundmanagement

Aachen, Germany

MVZ Hausärzte

Brüggen, Germany

ORGAMed

Dortmund, Germany

Hautklinik

Erlangen, Germany

Krankenhaus Tabea

Hamburg, Germany

WKM Rösner Mönchengladbach

Mönchengladbach, Germany

Gesundheitsmanager, Inh. Christine Bertram

Waidhaus, Germany

WKM Rösner Willich

Willich, Germany

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NCT07316556