Идёт набор NCT06442657

Pressure Sore Prevention Strategy for the Prone Position

Без фазы С лечением Pressure Ulcers Prevention in Prone Positioning in Intensive Care

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: Hydrocellular dressing, Hydrocolloids dressing.
Кому может быть актуально: Состояния в реестре: Pressure Ulcers Prevention in Prone Positioning in Intensive Care. Базовые параметры: 18 лет — 110 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: Франция
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

Comparison of Two Care Strategies (5-layer Hydrocellular Dressings Versus Thick Hydrocolloid Dressings) in Preventing the Development of Pressure Sore Lesions Induced by Prone Positioning in Intensive Care Patients. Multicenter Randomized Controlled Trial

Обзор

The aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. The main questions it aims to answer are: \- are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? The researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position. Participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.

Подробное описание

Hydrocellular dressings will be compared with hydrocolloid dressings to determine their effectiveness in preventing pressure ulcers during ventral decubitus in intensive care. The dressings will cover the skin in at-risk areas, and caregivers will assess whether or not pressure sores develop in these areas after prone positioning. The stage of these pressure sores will also be assessed.

The time spent on each strategy and the cost per strategy will also be evaluated. Dressings will be applied for the entire period during which participants are placed in the prone position. If they develop pressure sores during this period, they will be followed up until their discharge from intensive care to study the evolution of these pressure sores.

Вмешательства

Другое Hydrocellular dressing
Application of hydrocellular dressings to at-risk areas prior to prone positioning. Assessment of pressure sores and their stage after prone positioning.
Другое Hydrocolloids dressing
Application of hydrocolloids dressings to at-risk areas prior to prone positioning.

Первичные конечные точки

Compare the time to onset of one or more pressure ulcers during Ventral Decubitus(VD) sessions in the ICU with the type of preventive dressing selected (thick hydrocolloid or 5-layer hydrocellular) [Срок оценки: 30 minutes after being put back on its back]

Вторичные конечные точки (5)

Compare the location of pressure sores between the two groups [Срок оценки: 30 minutes after putting the participant back on his back]
Compare the severity of pressure sores between the two groups [Срок оценки: 30 minutes after putting the participant back on his back]
Compare the evolution of pressure sores between the two groups up to discharge from the intensive care unit. [Срок оценки: 30 minutes after the participant has been put back on his back after each prone session, then at D7, D14 and D28 or at discharge from intensive care if the participant has had a pressure sore]
Compare the care required to apply, monitor and remove the two types of dressing [Срок оценки: Three years]
Compare the cost of medical devices, by dressing strategy, until VD sessions are discontinued [Срок оценки: Three years]

Критерии участия

Критерии включения

Major patient
Moderate to severe acute respiratory distress syndrom (Arterial oxygen pressure /Inspired Fraction of oxygen ratio < 200) requiring at least one VD session.
Affiliated to the French social security system
Sedated patient on mechanical ventilation