AzTrials
AzTrials

Diaper RashNCT03309059

Comparison of Barrier Products in the Prevention of Incontinence-associated Dermatitis in Hospitalized Elderly

A study testing water and soap, zinc oxide and Non-Irritant Barrier Film in people with Diaper Rash, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Diaper Rash
What is being tested?
water and soap, zinc oxide and Non-Irritant Barrier Film
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteBrazil
Study dates
May 2016to 1 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Risoleta Tolentino Neves Hospital

    Belo Horizonte, Minas Gerais, 31744 012

Other trials in Brazil

About this study

Official title: 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

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.

Read the 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.

There is a high prevalence of chronic-degenerative diseases that imposes a need for greater hospitalization and progressive loss of the autonomy of the elderly. In this context, when IAD affects them, it is necessary to consider that the skin presents a sequence of alterations resulting from the aging process, making it more susceptible to the appearance of infections, wounds that consequently require a longer time for the process of aging. Healing occurs.

Demonstrate that the topic is little discussed by health professionals who care for the elderly population, and nursing has provided assistance based on experience gained in childcare, not based on scientific evidence to address the problem in Adults and the elderly. Thus, this situation may not address the needs of the care that the skin of the elderly may require.

The use of the diaper has been reported as one of those responsible for the appearance of dermatological disorders and exacerbation of episodes of urinary incontinence and decrease in the quality of life of these individuals. However, have identified specific care for the prevention and treatment of the IAD problem. However, they have not been tested and directed to the elderly population.

The measures are considered to be rather complex but relevant. For prevention, it is necessary to avoid or minimize exposure to causal factors by combining specific skin care, such as correct and gentle cleansing of the area, application of ointment or paste to protect against moisture and skin maceration.

Cleaning the skin with soap and water are traditionally used, as it is a common and necessary procedure, both at home and in the hospital. The wash removes organic debris from the surface of the skin, including scaly cells, fat and microorganisms. Water participates in the elimination of waste through mechanical and chemical action. The soap has surfactants that favor cleaning since they reduce the surface tension of the water, considering that the water in the soap also eliminates the residues. However, the surfactants contained in the soap can cause contact dermatitis, besides removing the hydrolipidic mantle by drying effect and thus weakening the protective function of the skin.

In addition to proper sanitization, the application of zinc oxide, which is a protective agent that promotes an occlusive barrier, is indicated which is able to prevent the passage of liquid from the inside out of the stratum corneum and prevents undesirable results from contact with urine And feces. It is commonly used due to its accessibility, resistance and cost, however, although it is more accessible, its long-term use may impose more costs on institutions.

A non-irritating alcohol-free product called Non-Irritant Barrier Film (PBNI) has been on the market since the 1990s. It is a mixture based on hexamethyldisiloxane, isoctane, thermopolymer acylate and polyphenylmethylsiloxane which upon contact with air forms a transparent, fluid impermeable, non-tissue irritating and non-cytotoxic film. It acts as a protection between skin and fluids and ease of application and removal, skin visibility and reduction of the frequency of incontinence-associated dermatitis are advantages of using film.

Defend the need for studies that present strong evidence for the prevention and treatment of IAD. In this sense, it is considered necessary to determine the efficacy of the products available for the prevention of the Nursing Diagnosis (ED) of Impaired Skin Integrity related to the use of diapers.

Considering these considerations, and due to the scarce knowledge about the best skin care of elderly patients with fecal and / or urinary incontinence, hospitalized in medical clinics indicated in the prevention of IAD, the following questions are asked: the use of the disposable diaper associated with Zinc oxide paste is more effective when compared to the use of disposable diaper associated with Non-Irritant Barrier Film in the prevention of incontinence-associated dermatitis?

Hypothesis H0 = The use of the disposable diaper associated with the previous cleaning with soap and water and subsequent application of zinc oxide is equivalent to the use of the disposable diaper associated with previous cleaning with soap and water and subsequent application of the non-irritating barrier film in the prevention of IAD In elderly incontinent patients admitted to a medical clinic.

H alternative = The use of the disposable diaper associated with cleaning with soap and water and subsequent application of Non Irritant Barrier Film is more effective in the prevention of IAD in elderly patients admitted to a medical clinic.

goal General objective To evaluate the effect of using zinc oxide ointment compared to Non-Irritant Barrier Film in the prevention of diaper dermatitis in elderly patients with faecal and / or urinary incontinence admitted to a medical clinic.

Specific objectives Identify risk factors for the development of impaired skin integrity related to faecal and / or urinary incontinence as evidenced by diaper area dermatitis in the hospitalized elderly population.

Identify changes in the skin in the diaper region during the use of the diaper with the application of zinc oxide.

Identify skin changes in the area of the diaper during the use of the diaper with the application of Non-Irritant Barrier Film.

Compare the best intervention for the prevention of diaper area dermatitis, a sign of impaired skin integrity, considering the need of the elderly population.

Outcome It will be considered a primary outcome of this study: whole skin in the area of diaper use with the use of soap and water and zinc oxide ointment; Skin integrity in the area of diaper use with the use of soap and water and Non-Irritant Barrier Film.

Population and Sample The population of this study will be composed of all the elderly patients who are bedridden and who present with discontinuation of the sphincter, who use a disposable diaper and who meet the inclusion criteria.

The sampling scheme used for data collection will be simple random sampling, within each of the groups studied. Thus, each sample unit within the population has the same probability of being selected to be part of the sample. In this study, a patient could be selected once, configuring a simple random sample without replacement.

To determine the minimum sample size required to detect significant differences between different treatments it is necessary to define a priori the minimum difference for which the test will present a significant result, the value of the desired power in addition to the level of significance of the test and the deviation Characteristics to be compared for the study population. The significance used to calculate the sample size will be 0.05. Thus, a significant difference will be considered for results whose probability of significance of the test, p-value, is less than or equal to 5%.

For this research, sample sizes were initially calculated considering power values at levels of 0.80 (80%), 0.90 (90%) and 0.95 (95%). The sample size was calculated considering the values of the statistical significance of the test, minimum significant difference in terms of 1, 0.75, 0.50 and 0.25 standard deviations and test power as described above.

The study by Chimentão and Domansky (2012) was used to calculate the prevalence of IAD in elderly patients in the nursing home (7%).

With these results, it was decided by a number of patients that will be part of the study of 79 for each of the groups studied. With this sample size it will be possible to identify differences from 0.5 standard deviations, with a power of 80% and a significance of 0.05.

The sample and the random allocation will be performed, using statistical technique and using a specific computer program. The time when this will be done will be as close as possible to the time of the intervention. The secrecy of the allocation list will be maintained.

Conditions
Diaper Rash
Being tested
water and soap, zinc oxide, Non-Irritant Barrier Film
Keywords
Nursing care, diaper rash, fecal incontinence, urinary incontinence
Medical subject headings
Diaper Rash, Fecal Incontinence, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • water and soapDevice

    Use of soap and water in the area and subsequent diaper placement disposable.

  • zinc oxideDevice

    Use of soap and water sanitation and application of zinc oxide.

  • Non-Irritant Barrier FilmDevice

    Use of soap and water hygiene and application of Non Irritant Barrier Film.

Study groups in NCT03309059
Study groupRoleWhat they receive
water and soapPlacebo comparatorWill 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.
Receives: Device: water and soap
zinc oxideActive comparatorwill 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.
Receives: Device: zinc oxide
Non-Irritant Barrier FilmExperimentalwill 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.
Receives: Device: Non-Irritant Barrier Film

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin integrity assessment

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study startMay 2016
  3. Primary completionNov 2017
  4. Study completion1 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03309059
Sponsor's protocol ID
x2mmdd79
Status last verified
Jul 2018
First submitted
15 Jan 2017
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.

    PubMed 21490547
  • Fernandes JD, Machado MC, Oliveira ZN. [Clinical presentation and treatment of diaper dermatitis--part II]. An Bras Dermatol. 2009 Jan-Feb;84(1):47-54. doi: 10.1590/s0365-05962009000100007. Portuguese.

    PubMed 19377759
  • ROCHA, N.; SELORES, M. Dermatite das fraldas. Nascer e Crescer- Revista do Hospital de Crianças Maria Pia. 2004:3 206-14

  • BLISS, D.Z; LOWRY, A; WHITEBIRD, R; SAVIK, K; FAN, Q; JUNG, H.J. Absorbent product use and incontinence associated dermatitis in community-living persons with fecal incontinence. Abstracts of the 38th Annual Meeting of the International Continence Society; October, 2008 In: DOMANSKY, R.C; BORGES, E.L. Manual para prevenção de lesões de pele. Recomendações baseadas em evidências. RJ: Editora Rubio, 2012. 270p.

  • AQUINO, A.L.; CHIANCA, T.C.M., BRITO R.C.S. Integridade da pele prejudicada, evidenciada por dermatite da área das fraldas: revisão integrativa. Rev. Eletr. Enf. [Internet]. 2012 abr/jun;14(2):414-24.

  • Newman DK, Fader M, Bliss DZ. Managing incontinence using technology, devices, and products: directions for research. Nurs Res. 2004 Nov-Dec;53(6 Suppl):S42-8. doi: 10.1097/00006199-200411006-00007.

    PubMed 15586147

Questions about this trial

What is this clinical trial studying?

A study testing water and soap, zinc oxide and Non-Irritant Barrier Film in people with Diaper Rash, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin integrity assessment (time frame: Through the use of data collection instrument the skin will be evaluated at the 13 day follow up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309059, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in