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Completed NCT07637695

Silicone Barrier Spray Versus Zinc Oxide Ointment for Incontinence-Associated Dermatitis

Conditions: Incontinence-Associated Dermatitis, Dermatitis, Skin Barrier Dysfunction

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Taoyuan Armed Forces General Hospital

Location: Taoyuan Armed Forces General Hospital Longtan Taoyuan City

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07637695). StuddyBuddy aggregates publicly available trial information.