infected wounds and wounds at risk L89 L97 I79.2 T81.4 C44.9
Conditions
Interventions
Group 1: This is a prospective multicenter single-arm cohort study.
During the inclusion visit (V1) the patients will have clinical examination and wound area measurements. Then the patients will rec
Sponsors
Lohmann & Rauscher GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Patient is legally capable • Presence of a wound according to the instruction for use: - venous leg ulcer or - arterial ulcer (ABPI 0,5) or - pressure ulcer (category II – IV) or - diabetic foot ulcer or - post-operative wound healing disturbance or - exulcerating tumors • Infected wound or wound with risk of infection (W.A.R. Score = 3) • Estimated survival time > 8 weeks • Wound area between 4 und 20 cm2 • Patient has signed written Informed Consent
Exclusion criteria
Exclusion criteria: • Treatment with Vliwaktiv® Ag Activated Charcoal Dressing and Rope with Silver or a similar dressing during the last 4 weeks prior to study start • Known sensitivity to Vliwaktiv® Ag Activated Charcoal Dressing and Rope with Silver or any of their components • Critical limb ischemia • Planned amputation in the next 2 months • A planned surgical operation in the region of the study wound in the next 8 weeks following inclusion • Patient is not compliant regarding treatment of the underlying disease (e.g. compression) • Dry wound • Pregnancy or breast feeding • Reliable severe malnutrition • Patient is analphabet • Participation in a therapeutic trial in the last 3 months and during participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The wound shift (reduction of necrotic tissue/fibrin slough and increase of granulation / epithelisation) after application of Vliwaktiv® Ag Activated Charcoal Dressing and Rope with Silver for 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of infection, reduction of infection signs and pain, reduction of exudation, reduction of odour, frequency and severity of device related adverse events and incidents. | — |
Countries
Poland
Contacts
Public ContactKrystyna Twardowska-Saucha
Specjalistyczna Pomoc Medyczna „Medservice”
Outcome results
None listed