Post-Marketing Surveillance of Vliwazell® Prowound Dressing

Lohmann & Rauscher208 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

208

Conditions

Acute and Chronic Wounds

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Vliwazell® Pro User Satisfaction with Exudate Management

The primary objective of this PMCF study is to assess the user satisfaction with exudate management during the use of Vliwazell® Pro. The primary performance parameter is defined as the proportion of users reporting a degree of satisfaction with exudate management after two weeks of treatment that is equal to or better than 4 ("acceptable"). Exudate management is assessed using a six-point Likert scale, ranging from excellent (1), very good (2), good (3), acceptable (4), poor (5), to insufficient (6). After two weeks of treatment, users will be asked to rate the exudate management using the six-level Likert scale. Treatment success is considered achieved when the mean score is equal to or better than "acceptable."

Time frame: From enrollment to the end of treatment at 2 weeks

Secondary Outcomes

Improvement of wound condition

One secondary endpoint is the improvement of the wound condition which is measured via a six-level scale: Excellent (1), very good (2), good (3), acceptable (4), poor (5), and insufficient (6). During the termination visit, after two weeks of treatment with Vliwazell® Pro more than 50% of the users should rate the improvement of the wound condition as "acceptable" or better.

Time frame: From enrollment to the end of treatment at 2 weeks

Safety evaluation: Incidence of maceration of wound or surrounding skin

Monitoring of deterioration of macerated wound surrounding skin or new development of maceration. Monitoring of deterioration of macerated wound surrounding skin or new development of maceration.Maceration will be monitored via adverse event reporting. The assumption is to have less than one third (\<33%; in terms of all patients) adverse events with product relationship (excluding user errors) assignable to the event maceration within the course of the study. Adverse events are collected via case report form AE log. AEs meeting criteria for seriousness are reported via SAE case report form and have to be reported to sponsor immediately

Time frame: From enrollment to the end of treatment at 2 weeks

Safety evaluation: Incidence of skin damage due to adhesion of wound dressing

Monitoring of adverse events related to damage of surrounding skin caused by dressing adhesion. Allergic reactions excluded.The assumption is to have less than one third (\<33%; in terms of all patients) adverse events with product relationship (excluding user errors) assignable to a damage of the skin surrounding the wound.