AI-Powered Research

Patients with acute and chronic wounds
- Wounds with moderate to very high amounts of exudate
- Non-infected wounds, wounds at risk of infection, infected
wounds
- All indications listed in the Vliwasorb® Pro IFU
- Arterial-venous (mixed”) leg ulcerations with a relevant, but not
critical arterial proportion
- Patient over 18 years of age
- Patient has signed written Informed Consent Form
- Patient agreed to comply with study treatment and planned study
visits

Exclusion Criteria

Use of Vliwasorb® Pro wound dressing is contraindicated according
to the current IFU:
- Known hypersensitivity to the product or its 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.
In addition the following patients shall excluded from this study:
- Patients unable to understand the use of the VAS tool.
- Pregnant or lactating women
- Patients participating in another clinical trial at the time of
inclusion
- Patient not covered by health insurance/social security
- Patients not able to give written Informed Consent
- Patients not legally capable

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Condition of the periwound skin (maceration, erythema [redness])<br><br>Primary Endpoints<br>The condition/assessment of the skin surrounding the wound (maceration, erythema/redness) measured using a 5-point Likert scale (none, minimal, moderate, severe, very severe) after 21 days serves as the primary performance parameter.<br><br>Visit 1: Inclusion visit (Day 1), first application of Vliwasorb® Pro<br>• Visit 2: First dressing change, second application of Vliwasorb® Pro<br>• Visit 3: Second dressing change, third application of Vliwasorb®Pro<br>• Visit 4: Third dressing change, fourth application of Vliwasorb®Pro<br>• Visit 5: Final Evaluation (Day 21 ± 3 days)

Secondary Outcome Measures

Name	Time	Method
Wound bed condition (percentage of necrotic, fibrinous,<br>granulating and epithelizing tissue)<br>Grade of exudation<br>Odour<br>Patients´ pain upon dressing removal<br>Dryness of the periwound skin<br>Safety<br><br>Secondary Endpoints<br>• Degree of exudation<br>• Integrity of the skin around the wound<br>• Condition of the skin around the wound (dermatitis, inflammation, dryness)<br>• Patient pain when the patient removes the bandage<br>• Condition of the wound bed (necrotic, fibrinous, granulating and epithelial tissue)<br>• Wound odor<br>• Wound infection<br>• Atraumatic dressing removal<br>• Safety: Device Defects (DDs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Product Effects (ADEs), Serious Adverse Product Effects (SA-DEs)