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- Ensayo clínico NCT07637695
Silicone Barrier Spray Versus Zinc Oxide Ointment for Incontinence-Associated Dermatitis
Effectiveness of Structured Skin Care Using Silicone Barrier Spray Compared With Zinc Oxide Ointment for Incontinence-Associated Dermatitis in Long-Term Care Residents: A Randomized Controlled Trial
Incontinence-associated dermatitis (IAD) is a common skin condition among long-term care residents and is caused by prolonged exposure to urine or feces. IAD can lead to skin irritation, discomfort, impaired skin integrity, and an increased risk of secondary complications. Structured skin care, including cleansing and barrier protection, is recommended for the prevention and management of IAD.
This randomized controlled trial evaluated the effectiveness of a silicone barrier spray compared with zinc oxide ointment as part of a structured skin care program for residents with mild IAD in a long-term care facility. Participants were randomly assigned to receive either silicone barrier spray or zinc oxide ointment following routine skin cleansing. Clinical severity of IAD and skin barrier function were assessed at baseline, Day 7, and Day 14 using standardized clinical and biophysical measurements, including IAD severity score, skin hydration, transepidermal water loss, skin pH, and skin temperature. The study aimed to determine whether silicone barrier spray provides comparable or improved outcomes compared with conventional zinc oxide ointment in the management of mild IAD.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Incontinence-associated dermatitis (IAD) is a common form of moisture-associated skin damage resulting from prolonged exposure of the skin to urine and/or feces. The condition is particularly prevalent among residents of long-term care facilities because of advanced age, reduced mobility, cognitive impairment, chronic illness, and urinary or fecal incontinence. IAD is associated with erythema, discomfort, pain, impaired skin barrier function, and an increased risk of secondary complications, including pressure injuries and skin infections.
Maintenance of skin barrier integrity is a fundamental component of IAD prevention and treatment. Current international guidelines recommend structured skin care programs consisting of routine cleansing, moisturization, and barrier protection. Zinc oxide-based ointments are among the most commonly used barrier products because they provide effective protection against moisture and irritants. However, zinc oxide formulations may be difficult to apply and remove, can leave residue on the skin, and may increase friction during repeated cleansing procedures.
Silicone-based barrier films represent an alternative approach to skin protection. These products form a transparent, breathable, water-resistant layer on the skin surface and may reduce friction while preserving epidermal barrier function. Sprayable silicone barrier formulations may provide additional practical advantages, including rapid application, uniform coverage, reduced physical contact with damaged skin, and improved ease of use for caregivers. Such characteristics may be particularly valuable in long-term care settings where frequent skin care interventions are required.
Despite increasing clinical use of silicone-based barrier products, direct randomized comparisons between sprayable silicone barrier films and traditional zinc oxide ointments remain limited. Furthermore, objective evaluations of skin barrier recovery using biophysical measurements have not been extensively investigated in long-term care populations with IAD.
The purpose of this study was to compare the effectiveness of a silicone barrier spray and zinc oxide ointment when incorporated into a structured skin care program for long-term care residents with mild incontinence-associated dermatitis. In addition to evaluating clinical improvement, the study investigated changes in skin barrier function using objective biophysical assessments. The findings of this study are intended to provide evidence to support clinical decision-making regarding barrier protection strategies and to improve skin care practices for vulnerable older adults residing in long-term care facilities.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taoyuan City
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Longtan, Taoyuan City, Taiwán, 325
- Taoyuan Armed Forces General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Resident of a long-term care facility.
- Diagnosis of mild incontinence-associated dermatitis (IAD), classified as GLOBIAD Category 1.
- Ability to provide informed consent personally or through a legally authorized representative.
- Willingness to participate in the study and comply with study procedures.
Exclusion Criteria:
- Incontinence-associated dermatitis (IAD) classified as GLOBIAD Category 2.
- Presence of skin erosion, skin loss, open wounds, or active skin infection in the assessment area.
- Known allergy or hypersensitivity to silicone-based barrier products or zinc oxide preparations.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Silicone Barrier Spray
Participants received a silicone-based barrier spray after structured skin cleansing and moisturizing care throughout the 14-day study period.
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A silicone-based skin barrier spray (Brava® Skin Barrier Spray, Coloplast A/S, Denmark) was applied to the perineal skin after each cleansing episode as part of a structured skin care regimen.
The spray forms a transparent, breathable, water-resistant protective film designed to reduce moisture-related skin damage and friction while maintaining skin barrier integrity.
Participants received the intervention throughout the 14-day study period following routine cleansing and moisturizing care.
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Comparador activo: Zinc Oxide Ointment
Participants received zinc oxide ointment after structured skin cleansing and moisturizing care throughout the 14-day study period.
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A traditional zinc oxide-based barrier ointment applied to the perineal skin after routine cleansing and moisturizing care.
The ointment forms a protective barrier that helps reduce skin exposure to moisture, irritants, and friction associated with urinary and fecal incontinence.
The intervention was administered as part of a structured skin care protocol throughout the 14-day study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Incontinence-Associated Dermatitis Severity Score
Periodo de tiempo: Baseline (Day 1), Day 7, and Day 14
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Clinical severity of incontinence-associated dermatitis assessed using the modified Ghent Global Incontinence-Associated Dermatitis Monitoring Tool (GLOBIAD-M).
Scores ranged from 0 (normal skin) to 2 (more severe dermatitis), with lower scores indicating improvement in skin condition.
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Baseline (Day 1), Day 7, and Day 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skin Hydration
Periodo de tiempo: Baseline (Day 1), Day 7, and Day 14
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Skin hydration measured using stratum corneum capacitance at affected skin sites.
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Baseline (Day 1), Day 7, and Day 14
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Transepidermal Water Loss (TEWL)
Periodo de tiempo: Baseline (Day 1), Day 7, and Day 14
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Skin barrier function assessed by measuring transepidermal water loss (g/m²/h) using a closed-chamber evaporimeter.
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Baseline (Day 1), Day 7, and Day 14
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Skin pH
Periodo de tiempo: Baseline (Day 1), Day 7, and Day 14
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Skin surface pH measured at affected skin sites using a flat-surface electrode device.
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Baseline (Day 1), Day 7, and Day 14
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Skin Temperature
Periodo de tiempo: Baseline (Day 1), Day 7, and Day 14
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Skin temperature measured at affected skin sites using a skin assessment device.
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Baseline (Day 1), Day 7, and Day 14
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Po Jen Hsiao, MD, PhD, Taoyuan Armed Forces General Hospital
- Silla de estudio: Hsieh Chih Tsai, PhD, National Taiwan University of Science and Technology
- Director de estudio: Po Chung Chen, MD, MS, Taoyuan Armed Forces General Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Bernatchez SF, Mengistu GE, Ekholm BP, Sanghi S, Theiss SD. Reducing Friction on Skin at Risk: The Use of 3M Cavilon No Sting Barrier Film. Adv Wound Care (New Rochelle). 2015 Dec 1;4(12):705-710. doi: 10.1089/wound.2015.0628.
- Holroyd S, Graham K. Prevention and management of incontinence-associated dermatitis using a barrier cream. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S32-8. doi: 10.12968/bjcn.2014.19.Sup6.S32.
- McNichol LL, Ayello EA, Phearman LA, Pezzella PA, Culver EA. Incontinence-Associated Dermatitis: State of the Science and Knowledge Translation. Adv Skin Wound Care. 2018 Nov;31(11):502-513. doi: 10.1097/01.ASW.0000546234.12260.61.
- Van den Bussche K, Verhaeghe S, Van Hecke A, Beeckman D. The Ghent Global IAD Monitoring Tool (GLOBIAD-M) to monitor the healing of incontinence-associated dermatitis (IAD): Design and reliability study. Int Wound J. 2018 Aug;15(4):555-564. doi: 10.1111/iwj.12898. Epub 2018 May 24.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TYAFGH-D-112032
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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