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Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers

RecruitingNAAges 18 Years - anyAllLohmann & Rauscher
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In plain words

What the trial is, and whether it could suit you

This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Infected\* venous\*\* leg ulcer * Slightly to moderately exuding wound\*\*\* * Patient has signed informed consent * as per CDC definition, also TILI score ≥ 5 \*\* ABPI \> 0.8 and \< 1.2 \*\*\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases Exclusion Criteria: * Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study * Wounds with exposed cartilage tissue (hyaline cartilage) * Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin) * Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage) * Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.
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What it tests

  • PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
  • PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
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Where

9 sites
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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