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

NCT07637695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

  • Incontinence-Associated Dermatitis
  • Dermatitis
  • Skin Barrier Dysfunction

Interventions

DEVICE

Silicone 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.

DRUG

Zinc 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 & Collaborators

  • Taoyuan Armed Forces General Hospital

    lead OTHER_GOV

Principal Investigators

  • Po Jen Hsiao, MD, PhD · Taoyuan Armed Forces General Hospital

  • Hsieh Chih Tsai, PhD · National Taiwan University of Science and Technology

  • Po Chung Chen, MD, MS · Taoyuan Armed Forces General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637695 on ClinicalTrials.gov