Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of Incontinence-associated Dermatitis (IAD)
研究概览
简要总结
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.
详细描述
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged and direct contact of the skin with urine and/or stool. It may occur in all age groups but elderly and care-dependent incontinent people are often affected by this type of inflammation. Promotion of continence, use of absorbent products and structured skin care are recommended to prevent and/or treat IAD. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. Currently, there is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory randomized controlled trial in incontinent elderly nursing home residents and geriatric patients will be conducted. In the two intervention groups, a film-forming or a lipophilic skin protection product will be applied in addition to standardized skin care regimens. Every other day, investigators will perform skin inspections, including instrumental skin measurements to quantify erythema for a total study period of n= 14 days. IAD- related pain and itch will be assessed. A total of n= 210 nursing home residents and geriatric patients in Berlin, Germany, aged over 65 years, who are affected by urinary and faecal incontinence without signs of severe IAD will be included.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Geriatric patients or residents being incontinent of urine and stool
- •Expected minimum length of stay of 14 days at the care facility
- •Intact skin with no clinical signs of IAD OR
- •intact skin with early clinical signs of IAD (IAD category 1A)
- •Written informed consent
排除标准
- •Residents/patients at the end of life
- •Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
- •Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
- •Known hypersensitivity or allergy to silicones and/or topical leave-on products
- •Topical treatments in the IAD area.
研究组 & 干预措施
ESENTA™ Skin Barrier Spray
In the intervention group I, standardized mild skin cleansing regimen and daily topical application of a film-forming skin protectant at the exposed skin areas will be applied by nursing staff.
干预措施: ESENTA™ Skin Barrier Spray (ConvaTec, UK) (Other)
Hydrophobes Basisgel DAC
In the intervention group II, standardized mild skin cleansing regimen and daily topical application of a hydrophobic skin protectant at the exposed skin areas will be applied by nursing staff.
干预措施: Hydrophobes Basisgel DAC (Other)
Standard Care
In the control group, standardized mild skin cleansing regimen without application of an additional skin protectant will be conducted by nursing staff.
结局指标
主要结局
Incidence of Incontinence-associated Dermatitis (IAD)
时间窗: 14 Days
Number of subjects developing IAD of all subjects (cumulative incidence). Classification of IAD according to Ghent Global IAD Categorisation Tool (GLOBIAD) (Category 1A, 1B, 2A, 2B). The GLOBIAD categorises IAD severity based on visual inspection of the affected skin areas. Category 1A: Persistent redness without clinical signs of infection Category 1B: Persistent redness with clinical signs of infection Category 2A: Skin loss without clinical signs of infection Category 2B: Skin loss with clinical signs of infection
次要结局
- Erythema (Instrumental Measurement)(14 Days)
- Erythema (Visual Inspection)(14 Days)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(14 Days)
- Incidence of Erosion(14 Days)
- Incidence of Maceration(14 Days)
- IAD Related Pain(14 Days)
- Incidence of IAD Related Itch(14 Days)
- Presence of Local Intolerances(14 Days)
- Incidents and Serious Incidents(14 Days)
研究者
Prof. Dr. Jan Kottner
Principal Investigator
Charite University, Berlin, Germany