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Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
Sponsor: Lohmann & Rauscher
Summary
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
Official title: Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-09-23
Completion Date
2027-06-15
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.
Locations (9)
ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń
Bialystok, Poland
Centrum Medyczne Ultramed
Krakow, Poland
MelissaMed Poradnia Chirurgiczna
Lodz, Poland
Mikomed Spółka Z Ograniczoną Odpowiedzialnością
Lodz, Poland
Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne
Lodz, Poland
PP CLINIC Pietrzyk spółka partnerska lekarzy
Lublin, Poland
SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota
Ostróda, Poland
Lecran - Centrum Opieki Nad Ranami-Kunickiego
Wroclaw, Poland
Specjalistyczna Pomoc Medyczna "Medservice"
Zabrze, Poland