Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Обзор

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

Подробное описание

This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.

Вмешательства

• Устройство two sided debridement pad
  two sided debridement pad
• Устройство one sided debridment pad
  one sided debridment pad

Первичные конечные точки

• Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T. [Срок оценки: 1 day]

Вторичные конечные точки (8)

• Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator [Срок оценки: 1 day]
• Rate of device-related adverse events (device safety) [Срок оценки: 1 day]
• Change of wound bed condition, defined by the combination of the following parameters: [Срок оценки: 1 day]
• Wound related pain [Срок оценки: 1 day]
• Time needed for debridement [Срок оценки: 1 day]
• Amount of products [Срок оценки: 1 day]
• Patient satisfaction [Срок оценки: 1 day]
• User satisfaction [Срок оценки: 1 day]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patient is legally capable
• Patient has signed written informed consent
• Presence of one of the following wounds

• Venous lower leg ulcer
• Arterial ulcer
• Diabetic ulcer
• Pressure ulcer
• Post-operative wound healing by secondary intention
• Traumatic wound
• Surgical wound
• Burn or scald (grade III: after surgical debridement)
• Epidermolysis Bullosa
• Wound area >4cm2
• The entire wound area can be displayed on one photo from a distance of 25-30 cm
• Covered with at least 30% debris, necrosis, slough, fibrotic tissue

Критерии исключения

• Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
• Pregnancy or breast feeding
• Patient is illiterate
• Participation in a interventional clinical trial within the last 14 days and during participation in this study
• Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
• severe pain or hyperesthesia in the wound area
• history of drug or alcohol abuse
• chronic analgesic use (especially opioids) that could influence baseline pain perception
• cognitive impairment, which may affect the ability to accurately self-report pain
• Use of anaesthesia before the debridment procedure
• presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary

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

Открытое

Основная цель

Лечение

Центры проведения

Польша · 5 центров

• MelissaMed Poradnia — Lodz
• MIKOMED Sp. z.o.o. — Lodz
• NZOZ Neuromed M. i M. Nastaj — Lublin
• Specjalistyczny Osrodek Leczniczo Badawczy — Ostróda
• Lecran - Centrum Opieki Nad Ranami-Kunickiego — Wroclaw

Идентификаторы

NCT: NCT07312513 · 2024-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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