Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study

Официальное название

Effect of Different Types of Disposable Absorbent Sheets on the Local Skin Microclimate and Incidence of Incontinence-associated Dermatitis in Patients With Incontinence in the ICU: a Multicenter Randomized Controlled Trial

Обзор

To explore the feasibility of Jefcare Sterile Medical Sheets in preventing incontinence-associated dermatitis and maintaining a stable local skin microclimate in adult patients in the intensive care unit.

Подробное описание

Jefcare Sterile Medical Sheet is an incontinence care product designed by researchers following the Expert consensus on the clinical application of disposable absorbent care products for adults with incontinence. The product has good laboratory test indicators and has the potential to prevent incontinence-associated dermatitis and maintain the stability of the local skin microclimate. Still, there is a lack of high-quality clinical studies.

Вмешательства

• Устройство Jefcare Sterile Medical Sheets
  Screening period (day 0): normal routine medical sheet and skin care regimen. Intervention days 1, 2, 3, 4, 5: Jefcare Sterile Medical Sheets and skin care regimen.
• Устройство Molicare Premium Bed Mat
  Screening period (day 0): normal routine medical sheet and skin care regimen. Intervention days 1, 2, 3, 4, 5: MoliCare Premium Bed Mats and skin care regimen.

Первичные конечные точки

• Incidence of IAD [Срок оценки: Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.]

Вторичные конечные точки (7)

• The time of IAD occurrence [Срок оценки: Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.]
• The site and severity of IAD occurrence [Срок оценки: Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention]
• The skin microclimate and skin barrier function [Срок оценки: Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of the study i.e. day 5 of the intervention.]
• The skin microclimate and skin barrier function [Срок оценки: Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of the study i.e. day 5 of the intervention.]
• Date of faecal incontinence (post-intervention);Mean number of faecal incontinence per day (post-intervention). [Срок оценки: The average number of medical sheets used per day:Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.]
• Average daily cost-effectiveness of medical sheets. [Срок оценки: The average number of medical sheets used per day:Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.]
• Mycological examination [Срок оценки: Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of study i.e. day 5 of the intervention.]

Критерии участия

Критерии включения

• Intensive care unit incontinent patients (incontinence time ≥2 days)
• Age ≥18 years
• patients at high risk of IAD (Perineal Assessment Tool ≥ 7)
• Voluntarily participate in the study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to incapacitation or other reasons, their guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness will be required to witness the informed process and sign the informed consent form.

Критерии исключения

• Patients who have developed IAD
• Expected subsequent stay in the intensive care unit <5 days
• Use of nappies, pull-ups, incontinence pads, etc.
• Simple urinary incontinence with indwelling catheterization, external urinary bag without leakage; simple fecal incontinence with built-in drainage device, external ostomy bag, OB tampon without leakage; double incontinence with indwelling catheterization, external urinary bag, built-in drainage device, external ostomy bag, OB tampon without leakage.
• The IAD may affect the skin area within the scope of the disease that affects the IAD judgment.
• The IAD may affect the skin area within the scope of the skin breaks, infection
• Patients who are not suitable for turning and cannot tolerate the side-lying position.
• Patients with known allergies or keloid scarring
• Women who are known to be pregnant or breastfeeding or who are planning to have a baby during the study period.
• Patients who have participated in a clinical trial of another drug or medical device within 3 months.
• Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06644027 · 20240455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗