NCT07316556

Post-Marketing Surveillance of Vliwazell® Prowound Dressing

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 208 (estimated)
• Sponsor: Lohmann & Rauscher · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2024-03-11
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

8 sites across 1 country: Germany