Post-Marketing Surveillance of Vliwazell® Prowound Dressing

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."

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.

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

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.

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.

Monitoring of adverse events related to use in combination with wound irrigation solutions, primary/secondary dressings, wound fillers, or retention materials.The acceptance criterion for the requirement compatibility is no more than 15% adverse events with product relationship.

The pain felt by the patient regarding the wound and treatment of the wound is measured via the NRS-11 score. For this, the patient is asked to rate his/her level of pain on a scale from 0 (no pain) to 10 (severe pain). Two data measurements (question to the patient) are done directly before and after the treatment with Vliwazell® Pro at the visit 1/baseline visit. Last data measurements are done after the two weeks of treatment with Vliwazell® Pro at the visit 2 / termination visit

Secondary endpoint for the user satisfaction (Visit 1):

Users will be asked at Visit 1 if the selection of sizes for the wound dressing with 10 x 10cm, 10 x 20cm, 15 x 20cm 20 x 25cm and 20 x 40cm is satisfying their needs in daily practice. This parameter is measured on a Two-Point Scale (yes/no) and the assumption (it will not be statistically tested) is that ≥50% for the answer "yes" (for each feature).

At termination visit, users will be asked to assess predefined parameters related to dressing performance and usability. The assessment will be conducted using a six-level agreement scale:,These are measured via a six-level scale: 1- I totally agree, 2- I agree,3- Neither agree nor reject, 4- I disagree, 5-I totally disagree.

The assumption (not statistically tested) is that as ≥50% answer: "I totally agree" or "I agree".

The patient satisfaction will be collected by a quality of life (QoL) questionnaire typical for wounds. The questionnaire is asked for on initial and closed visits. On closed visit additional questions are included regarding the patient satisfaction. The patients will be asked if they think that Vliwazell® Pro is comfortable for them while wearing and whether they think that the wound dressing has a high wearing comfort. Additionally, they will be asked if clothing and bed linen are protected from soaking and if they feel protected from that by that the wound dressing.

These parameters are measured via a six-level scale: 1- I totally agree, 2- I agree,3- Neither agree nor reject,4- I disagree, 5-I totally disagree.

The assumption for each question is that ≥50% will answer: "I totally agree" or "I agree".