wound healing
Conditions
Interventions
Group 1: the study is single-arm.
The clinical examination is carried out for 21 days (± 3 days).
Vliwasorb® Pro is used for 3 dressing changes (? 4 times) or up to a maximum of 21 days (± 3 days).
A
Sponsors
Lohmann & Rauscher GmbH & Co.KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Condition of the periwound skin (maceration, erythema [redness]) Primary Endpoints 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. Visit 1: Inclusion visit (Day 1), first application of Vliwasorb® Pro • Visit 2: First dressing change, second application of Vliwasorb® Pro • Visit 3: Second dressing change, third application of Vliwasorb®Pro • Visit 4: Third dressing change, fourth application of Vliwasorb®Pro • Visit 5: Final Evaluation (Day 21 ± 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound bed condition (percentage of necrotic, fibrinous, granulating and epithelizing tissue) Grade of exudation Odour Patients´ pain upon dressing removal Dryness of the periwound skin Safety Secondary Endpoints • Degree of exudation • Integrity of the skin around the wound • Condition of the skin around the wound (dermatitis, inflammation, dryness) • Patient pain when the patient removes the bandage • Condition of the wound bed (necrotic, fibrinous, granulating and epithelial tissue) • Wound odor • Wound infection • Atraumatic dressing removal • Safety: Device Defects (DDs), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Product Effects (ADEs), Serious Adverse Product Effects (SA-DEs) | — |
Countries
Germany
Contacts
Public ContactPeter Lübke
Helios-Klinium
Outcome results
None listed