Post-Marketing Surveillance of Vliwazell® Prowound Dressing

Lohmann & Rauscher (L&R)

Status: Enrolling

Conditions: Acute and Chronic Wounds

Study type: Observational

Funder types: Industry

Identifiers

NCT07316556

2018-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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