Идёт набор NCT06300762

RCT Exudate Management Cutimed Sorbion Product Range

Без фазы С лечением Venous Leg Ulcer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Superabsorbent dressing application.
Кому может быть актуально: Состояния в реестре: Venous Leg Ulcer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range

Обзор

The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care. As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.

Вмешательства

Устройство Superabsorbent dressing application
Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate

Первичные конечные точки

Exudate management performance [Срок оценки: up to 30 days]

Вторичные конечные точки (8)

Dressing change frequency [Срок оценки: up to 30 days]
Moisture-associated skin damages [Срок оценки: up to 30 days]
Occurrence clinical relevant peri-wound skin changes [Срок оценки: up to 30 days]
Changes in wound tissue and general wound pain [Срок оценки: up to 30 days]
Need for debridement after product removal [Срок оценки: up to 30 days]
Patient satisfaction with treatment and product [Срок оценки: final study visit]
HCP satisfaction with treatment and product [Срок оценки: final study visit]
Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments) [Срок оценки: day 0 and day 30]

Критерии участия

Критерии включения

Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
Participant is mentally and physically able to participate in this study
Men, women, diverse ≥ 18 years
Participant complies with study visit schedule
Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
Participant suffers from lower leg ulcer\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
Ulcer is not younger than 4 weeks and not older than 1 year
Ulcer is ranging between 2 cm2 and 800 cm2
One side of the ulcer is not extending 40 cm
Depth of ulcer < 2 cm
Ankle-brachial pressure index (ABPI) of >0.8 and ≤1.3, measurement not older than 12 months \* Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.

Критерии исключения

Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
Participant is expected not to be willing or able to follow the study outlines and requirements
Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
Participant uses any medication that could potentially delay the wound healing ability
Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
Participant is pregnant or currently breastfeeding
Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone

8\. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis

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

Здоровые добровольцы: Нет