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临床试验/NCT03309059
NCT03309059已完成不适用

Comparison Between the Effect of Zinc Oxide and Non-irritant Barrier Film on the Prevention of Incontinence-Associated Dermatitis in Hospitalized Elderly in a Teaching Hospital

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
2
主要终点
Skin integrity assessment

研究概览

简要总结

In clinical practice, there are a large number of patients hospitalized with Incontinence-Associated Dermatitis. Studies are needed to determine the effectiveness of products available for disease prevention. It is believed that the use of the non-irritant barrier film is superior to the use of zinc oxide in the prevention of Incontinence-Associated Dermatitis. The objective of this study is to compare the effect of the use of zinc oxide ointment with the use of non-irritant barrier film in the prevention of diaper dermatitis in incontinent patients admitted to medical clinic units.

详细描述

Introduction Skin lesions associated with moisture are defined as inflammation and skin erosion arising from prolonged exposure to sources such as urine, feces, sweat, wound exudate, mucus and saliva. They are initially triggered by lesions of the corneal extract, induced by exposure to multiple factors such as hyperhydration, friction, temperature, chemical irritants, urine and feces.

Among these types of lesions there is Incontinence Associated Dermatitis (IAD) which is a common clinical manifestation in patients with urinary and / or fecal incontinence. It is a skin inflammation that occurs as a consequence of the contact of the perineal, perigenital, perianal and adjacent areas with the urine and feces, besides erosion of the epidermis and macerated appearance.

The prevalence of IAD was reported as responsible for 7% of skin lesions in incontinent patients in nursing homes, 50% of them with fecal incontinence and 42% in hospitalized incontinent adults.

That the hospitalized incontinent individual is exposed to extrinsic and intrinsic factors that increase the susceptibility to IAD. As intrinsic factors, age, level of consciousness, oxygenation, mobility and comorbidity are mentioned, while extrinsic factors are related to exposure to incontinence, humidity and friction, as well as the frequency and quality of hygiene. Elderly incontinents are particularly vulnerable to the development of IAD because they have fewer layers of corneal extract, and also show a gradual decline in the barrier function associated with collagen and elastin decrease, as well as a decrease in microcirculation.

Patients bedridden, dependent, without sphincter control make constant use of diapers. In this universe of patients, the elderly are hospitalized. They demand more health services, hospitalizations are more common and hospitalization time is higher.

研究设计

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

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 or older, exhibit stifle incontinence, wear disposable diapers, and be at risk for Incontinence-Associated Dermatitis

排除标准

  • Patients with allergic reaction to the products used in the study

研究组 & 干预措施

Non-Irritant Barrier Film

Experimental

will be composed of the elderly patients who present fecal and / or urinary incontinence and that, therefore, it is necessary to implement measures to prevent the development of ICD with the use of soap and water hygiene and application of Non Irritant Barrier Film. The patient who presents with urinary and / or fecal eliminations will undergo this intervention and then the placement of the disposable diaper used by the hospital.

干预措施: Non-Irritant Barrier Film (Device)

zinc oxide

Active Comparator

will be composed of elderly patients who present with fecal and / or urinary incontinence and who, therefore, need to implement measures to prevent the development of IAD with the use of soap and water sanitation and application of zinc oxide . The patient presenting with urinary and / or fecal eliminations will undergo such intervention and then the placement of the disposable diaper used by the hospital.

干预措施: zinc oxide (Device)

water and soap

Placebo Comparator

Will be composed of elderly patients who present with fecal and / or urinary incontinence and who, therefore, need to implement measures to prevent the development of IAD with the use of soap and water in the area and subsequent diaper placement disposable. This type of procedure is standardized in the medical clinic wards of the hospital under study, and for this reason, it was defined as control.

干预措施: water and soap (Device)

结局指标

主要结局

Skin integrity assessment

时间窗: Through the use of data collection instrument the skin will be evaluated at the 13 day follow up.

The skin of the perineal, perigenital, perianal and adjacent regions will be evaluated for the presence of Incontinence-Associated Dermatitis.

次要结局

未报告次要终点

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Lucia Goulart Constant Alcoforado

Assistant Professor, Department of Basic Nursing

Federal University of Minas Gerais

研究点 (2)

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