Dermatitis, Incontinence-Associated Dermatitis, Skin Barrier Dysfunction
Conditions
Keywords
incontinence-associated dermatitis, silicone spray, skin barrier, nursing care, long-term care
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilicone Barrier Spray
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.
DRUGZinc Oxide Ointment
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.
Sponsors
Taoyuan Armed Forces General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
No additional study personnel were masked beyond the outcome assessor. Due to the visible differences between the silicone barrier spray and zinc oxide ointment, participants and care providers were aware of treatment allocation. All clinical assessments and biophysical measurements were performed by an independent outcome assessor who remained blinded to group assignment throughout the study.
Intervention model description
Participants with mild incontinence-associated dermatitis (GLOBIAD Category 1) were randomized to one of two parallel groups. Both groups received identical structured skin care procedures. The intervention differed only in the barrier protection product used after cleansing: silicone barrier spray in the experimental group and zinc oxide ointment in the control group. Clinical and biophysical outcomes were evaluated longitudinally during the 14-day follow-up period.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Incontinence-Associated Dermatitis Severity Score | Baseline (Day 1), Day 7, and Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration | Baseline (Day 1), Day 7, and Day 14 | Skin hydration measured using stratum corneum capacitance at affected skin sites. |
| Transepidermal Water Loss (TEWL) | Baseline (Day 1), Day 7, and Day 14 | Skin barrier function assessed by measuring transepidermal water loss (g/m²/h) using a closed-chamber evaporimeter. |
| Skin pH | Baseline (Day 1), Day 7, and Day 14 | Skin surface pH measured at affected skin sites using a flat-surface electrode device. |
| Skin Temperature | Baseline (Day 1), Day 7, and Day 14 | Skin temperature measured at affected skin sites using a skin assessment device. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORPo Jen Hsiao, MD, PhD
Taoyuan Armed Forces General Hospital
STUDY_CHAIRHsieh Chih Tsai, PhD
National Taiwan University of Science and Technology
STUDY_DIRECTORPo Chung Chen, MD, MS
Taoyuan Armed Forces General Hospital
Outcome results
None listed