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

Официальное название

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

Обзор

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

Подробное описание

During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exudation status. Eligible patients with slight or moderate wound exudation will be randomly assigned to treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. The patients who fulfil all other eligibility criteria but have high level of wound exudation will enter a 7-days run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period they should receive appropriate treatment including systemic antimicrobial drug therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within this period or other eligibility criteria are not met anymore, they will be screened out.

Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression and, if necessary, systemic antimicrobial drug therapy. During the study participation, selected parameters of the wound will be assessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis. After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will complete the study. Their further treatment (if necessary), will not be the part of the study.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro) [Срок оценки: 3 weeks]

Вторичные конечные точки (10)

• Wound area change over time [Срок оценки: 3 weeks]
• Change of necrotic & fibrinous & granulation tissue rate in the wound bed [Срок оценки: 3 weeks]
• Change of wound infection status [Срок оценки: 3 weeks]
• Product safety (rate of product-related complications) [Срок оценки: 3 weeks]
• Change of wound exudation and presence of peri-wound oedema [Срок оценки: 3 weeks]
• Change in patient's pain [Срок оценки: 3 weeks]
• Product usability [Срок оценки: 3 weeks]
• Change in patient's quality of life [Срок оценки: 3 weeks]
• Oedema chamge [Срок оценки: 3 weeks]
• Sub-bandage pressure levels retention [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Польша · 9 центров

• ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń — Bialystok
• Centrum Medyczne Ultramed — Krakow
• MelissaMed Poradnia Chirurgiczna — Lodz
• Mikomed Spółka Z Ograniczoną Odpowiedzialnością — Lodz
• Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne — Lodz
• PP CLINIC Pietrzyk spółka partnerska lekarzy — Lublin
• SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota — Ostróda
• Lecran - Centrum Opieki Nad Ranami-Kunickiego — Wroclaw
• … и ещё 1 центр

Идентификаторы

NCT: NCT07211243 · 2024-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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