Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading

Charite University, Berlin, Germany2 个研究点分布在 1 个国家目标入组 15 人开始时间: 2016年9月最近更新: 2022年6月14日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Charite University, Berlin, Germany
入组人数: 15
试验地点: 2
主要终点: Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 60 Years 至 80 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy, female volunteers
•60 to 80 years
•Body Mass Index between 18.5 and 29.9 kg/m2
•Non-Smoker of at least one year
•Absence of skin diseases or scars in the skin areas of interest
•Ability to move independently and to maintain supine and prone positions
•Able to give written informed consent
•No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
•Skin phototype I to III according to Fitzpatrick classification
•Willing and able to fulfil the study requirements

排除标准

•Disability to maintain in supine or prone position
•Acute diseases
•Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
•History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
•Acute or chronic wounds in the skin areas of interest
•Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
•Participation in another clinical study 4 weeks before inclusion visit
•Current participation in any other clinical study