An observational study in Acute and Chronic Wounds, sponsored by Lohmann & Rauscher. Recruiting at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Lohmann & Rauscher · Observational
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.
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Wound according to indication mentioned in the instructions for use:
Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:
Exclusion Criteria:
Patient with :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: From enrollment to the end of treatment at 2 weeks.
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.
Safety evaluation: Compatibility with other wound care products
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.
Time frame: From enrollment to the end of treatment at 2 weeks.
Patient-reported wound pain intensity measured by NRS-11
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
Time frame: From enrollment to the end of treatment at 2 weeks.
User satisfaction and usability
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".
Time frame: From enrollment to the end of treatment at 2 weeks.
Patient satisfaction
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".
Time frame: From enrollment to the end of treatment at 2 weeks.
Plan to share: No — IPD will not be shared due to privacy considerations and the nature of the study.
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Jan 2027, 34 months after the start.
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