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

NCT07637695 | Completed

• 1 other identifier: TYAFGH-D-112032
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence-Associated Dermatitis; Dermatitis; Skin Barrier Dysfunction

Keywords

incontinence-associated dermatitis; silicone spray; skin barrier; nursing care; long-term care

Outcome Measures

Primary Outcomes (1)

• Change in Incontinence-Associated Dermatitis Severity Score

  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.

  Baseline (Day 1), Day 7, and Day 14

Secondary Outcomes (4)

• Skin Hydration

  Baseline (Day 1), Day 7, and Day 14

• Transepidermal Water Loss (TEWL)

  Baseline (Day 1), Day 7, and Day 14

• Skin pH

  Baseline (Day 1), Day 7, and Day 14

• Skin Temperature

  Baseline (Day 1), Day 7, and Day 14

Study Arms (2)

Silicone Barrier Spray

EXPERIMENTAL

Participants received a silicone-based barrier spray after structured skin cleansing and moisturizing care throughout the 14-day study period.

Device: Silicone Barrier Spray

Zinc Oxide Ointment

ACTIVE COMPARATOR

Participants received zinc oxide ointment after structured skin cleansing and moisturizing care throughout the 14-day study period.

Drug: Zinc Oxide Ointment

Interventions

Zinc Oxide Ointment DRUG

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.

Zinc Oxide Ointment

Silicone Barrier Spray DEVICE

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.

Silicone Barrier Spray

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taoyuan Armed Forces General Hospital: lead

Study Sites (1)

Taoyuan Armed Forces General Hospital

Longtan, Taoyuan City, 325, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 26634182 BACKGROUND

• 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.

  PMID: 25478854 RESULT

• 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.

  PMID: 30303813 RESULT

• 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.

  PMID: 29797507 RESULT

Related Links

• Manufacturer information for Brava Skin Barrier Spray used in the study.

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Po Jen Hsiao, MD, PhD

  Taoyuan Armed Forces General Hospital

  PRINCIPAL INVESTIGATOR

• Hsieh Chih Tsai, PhD

  National Taiwan University of Science and Technology

  STUDY CHAIR

• Po Chung Chen, MD, MS

  Taoyuan Armed Forces General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: January 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)