Prospective Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of Vliwaktiv® Ag

Phase 4

• Conditions: infected wounds and wounds at risk; L89; L97; I79.2; T81.4; C44.9; Decubitus ulcer and pressure area; Ulcer of lower limb, not elsewhere classified; Peripheral angiopathy in diseases classified elsewhere; Infection following a procedure, not elsewhere classified

• Registration Number: DRKS00015648
• Lead Sponsor: ohmann & Rauscher GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-02
• Study Start: 2018-10-09
• Results First Posted: 2024-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 58

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
- arterial and venous leg 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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.