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Идёт набор NCT06790277

Polyurethane Foam-Pink Pad (RCT) Use in OR

Без фазы С лечением Cardiac Surgery Subjects Pressure Ulcer Prevention Pressure Ulcer of Skin Pressure 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: Mepilex Border Sacrum dressings, Polyurethane foams (Pink Pad).
Кому может быть актуально
Состояния в реестре: Cardiac Surgery Subjects, Pressure Ulcer Prevention, Pressure Ulcer of Skin, Pressure 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
Саудовская Аравия
Следующий шаг
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Официальное название

Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial

Обзор

King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.

Подробное описание

There are two types of intervention available in King Abdullah medical city for operating room pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position.

Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention.

All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines ( European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the Braden Scale at hospital admission,

Вмешательства

  • Устройство Mepilex Border Sacrum dressings
    Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post
  • Устройство Polyurethane foams (Pink Pad)
    Both types of intervention will be available in the operating room. Patient will be examined by head nurse of wound management team after the operation then at day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there is any clinical indication for removal. If a patient is discharged before 7 days post operation for any reason the head nurse of wound management team will examine the patient before discharge. Follow up will be for maximum 7 days post

Первичные конечные точки

  • Pressure ulcer incidence [Срок оценки: 7 days]
Вторичные конечные точки (1)
  • occurrence of pressure ulcer [Срок оценки: 7 days]

Критерии участия

Критерии включения

  • Subjects ≥ 18.
  • Willing to participate.
  • Patients undergoing cardiac surgery.
  • Patient who is at risk for PU development as measured with Braden scale.
  • Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.

Критерии исключения

  • Subjects under 17
  • Not consenting to participate
  • Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients.
  • Patients who are unable to continue the study because of death or change in the care setting.

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
Профилактика

Центры проведения

Саудовская Аравия · 1 центр
  • King Abdulla Medical City in Holy capital — Mecca

Публикации

  • Elhihi EA, Almuwallad SA, Alqrashi BM, Nada EM, Alduaiji NA, Alfakeeh AA. Effectiveness of a Single-Use Polyurethane Foam Positioning Pad Compared With Five-Layer Foam Sacral Dressing for Pressure Ulcer Prevention in the Operating Room: A Randomized Controlled Clinical Trial. Health Sci Rep. 2025 Aug 10;8(8):e70963. doi: 10.1002/hsr2.70963. eCollection 2025 Aug. PMID 40791282

Идентификаторы

NCT: NCT06790277 · 23-1093 · 2323

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗