Feasibility Study of Jefcare Sterile Medical Sheets for the Prevention of Incontinence-associated Dermatitis and the Maintenance of Local Skin Microclimate Stability in Adult Patients in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of IAD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: MoliCare Premium Bed Mats (Device)
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.
干预措施: Jefcare Sterile Medical Sheets (Device)
结局指标
主要结局
Incidence of IAD
时间窗: 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.
incidence of IAD = number of cases of patients with IAD in the group/total number of patients in the group × 100%.
次要结局
- The site and severity of IAD occurrence(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 time of IAD occurrence(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(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 (ICU admission to end of study);Mean number of faecal incontinence per day (ICU admission to end of study);The average number of medical sheets used per day.(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(Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of study i.e. day 5 of the intervention.)