Evaluate the Efficacy of Two Advanced Skin Treatment Regimens in Treating Incontinence-associated Dermatitis: Cluster Randomization Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Proportion of Participants With IAD Healing
研究概览
简要总结
The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients
详细描述
The aim of this study is to evaluate the efficacy of two different skin care regimens (3M Cavilon Advanced Skin Protectant with 3M No-Rinse Cleanser and Coloplast Conveen Critic Barrier with Easi-Cleanser) against standard care (Skin wipes and Conveen Critic Barrier) in the management of Incontinence-Associated Dermatitis (IAD) in hospitalised patients.
To date, there is no conclusive evidence on the "best treatment" for patients presenting with IAD. This has led to current clinical practices tend to select IAD products based on its cost and availability, which can be heavily influenced by marketing and commercialisation efforts.
This study allows investigation of the effectiveness of IAD products to ensure the provision of optimal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years and above at point of recruitment
- •Diagnosed with IAD
- •At regular risk of exposure to urine and faeces over their hospitalization
排除标准
- •Having a known allergy to the treatment products
- •Haemodynamically unstable at point of assessment for study
- •Unable to tolerate lateral positioning for skin cleansing and treatment application
- •Pregnancy
- •Having an existing skin disease at point of study that might lead to inaccurate IAD assessment, such as herpes or scabies.
结局指标
主要结局
Proportion of Participants With IAD Healing
时间窗: Up to seven days from initiation of treatment
Percentage of participants who experienced IAD healing
Number of Participants Who Experienced IAD Healing
时间窗: Up to seven days from initiation of treatment
Total number of participants who experienced IAD healing
次要结局
- Number of Participants Who Developed Skin Loss(Up to three days from initiation of treatment)