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

NCT03309059 | Completed

• 1 other identifier: x2mmdd79
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaper Rash

Keywords

Nursing care; diaper rash; fecal incontinence; urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Skin integrity assessment

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

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

Study Arms (3)

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.

Device: water and soap

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.

Device: zinc oxide

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.

Device: Non-Irritant Barrier Film

Interventions

water and soap DEVICE

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

water and soap

zinc oxide DEVICE

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

zinc oxide

Non-Irritant Barrier Film DEVICE

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

Non-Irritant Barrier Film

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Risoleta Tolentino Neves Hospital

Belo Horizonte, Minas Gerais, 31744 012, Brazil

Location

Related Publications (6)

• 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.

  PMID: 21490547 BACKGROUND

• 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.

  PMID: 19377759 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15586147 BACKGROUND

MeSH Terms

Conditions

Diaper Rash; Fecal Incontinence; Urinary Incontinence

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Tania C Machado Chianca, Phd

  Federal University of Minas Gerais

  STUDY DIRECTOR

• Flavia F Ercole, Phd

  Federal University of Minas Gerais

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Basic Nursing

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: October 13, 2017
• Study Start: May 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)