- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Taoyuan City
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Longtan, Taoyuan City, Tajwan, 325
- Taoyuan Armed Forces General Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Incontinence-Associated Dermatitis Severity Score
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Skin Hydration
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Śledczy
- Główny śledczy: Po Jen Hsiao, MD, PhD, Taoyuan Armed Forces General Hospital
- Krzesło do nauki: Hsieh Chih Tsai, PhD, National Taiwan University of Science and Technology
- Dyrektor Studium: Po Chung Chen, MD, MS, Taoyuan Armed Forces General Hospital
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TYAFGH-D-112032
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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