Skip to main content
Clinical Trials/NCT03309059
NCT03309059CompletedNot Applicable

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 sites in 1 country138 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
138
Locations
2
Primary Endpoint
Skin integrity assessment

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: water and soap (Device)

Outcomes

Primary Outcomes

Skin integrity assessment

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Federal University of Minas Gerais
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carla Lucia Goulart Constant Alcoforado

Assistant Professor, Department of Basic Nursing

Federal University of Minas Gerais

Study Sites (2)

Loading locations...

Similar Trials

Comparison of Barrier Products in the... | Clinical Trial