Post-Marketing Surveillance of Vliwazell® Prowound Dressing
ConditionAcute and Chronic Wounds
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLohmann & Rauscher
About this trial
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
This trial does not accept healthy volunteersQualifiers
arterial and venous ulcers
diabetic ulcers
pressure ulcers
post-traumatic wounds
Disqualifiers
Age < 18 years
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.
Trial population
Investigators should enroll patients out of their normal patient pool. Exceptions are vulnerable patients like pregnant or lactating women, patients under 18 years or patient without full legal capacity.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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.
Time frame
From enrollment to the end of treatment at 2 weeks.4
Safety evaluation: Incidence of bursting of wound dressing
Safety parameters as low bursting (adverse device effect: bursting of wound dressing) is monitored by the adverse event reporting. The assumption is that no more than 15% (in terms of all patients) adverse events with product relationship assignable to the event bursting within the course of the study.
Time frame
From enrollment to the end of treatment at 2 weeks.Sponsors and contacts
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Source ClinicalTrials.gov