NCT07316556 Post-Marketing Surveillance of Vliwazell® Prowound Dressing
| NCT ID | NCT07316556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lohmann & Rauscher |
| Condition | Acute and Chronic Wounds |
| Study Type | OBSERVATIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 208 participants in total. It began in 2024-03-11 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Thomas Eberlain, Dr
PRINCIPAL INVESTIGATOR
Lohmann & Rauscher
Frequently Asked Questions
Who can join the NCT07316556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute and Chronic Wounds. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07316556 currently recruiting?
Yes, NCT07316556 is actively recruiting participants. Contact the research team at project@brunner-memmhardt.de for enrollment information.
Where is the NCT07316556 trial being conducted?
This trial is being conducted at Aachen, Germany, Brüggen, Germany, Dortmund, Germany, Erlangen, Germany and 4 additional locations.
Who is sponsoring the NCT07316556 clinical trial?
NCT07316556 is sponsored by Lohmann & Rauscher. The principal investigator is Thomas Eberlain, Dr at Lohmann & Rauscher. The trial plans to enroll 208 participants.