Incontinence-Associated DermatitisNCT07637695
Silicone Barrier Spray Versus Zinc Oxide Ointment for Incontinence-Associated Dermatitis
A study testing Silicone Barrier Spray and Zinc Oxide Ointment in people with Incontinence-Associated Dermatitis and Dermatitis, run by Taoyuan Armed Forces General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incontinence-Associated Dermatitis, Dermatitis, Skin Barrier Dysfunction
- What is being tested?
- Silicone Barrier Spray and Zinc Oxide Ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Silicone Barrier Spray, Zinc Oxide Ointment
- Keywords
- incontinence-associated dermatitis, silicone spray, skin barrier, nursing care, long-term care
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Barrier SprayDevice
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.
Zinc Oxide OintmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Barrier Spray | Experimental | Participants received a silicone-based barrier spray after structured skin cleansing and moisturizing care throughout the 14-day study period. Receives: 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. Receives: Drug: Zinc Oxide Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1), Day 7, and Day 14
Secondary outcomes (4)
Skin Hydration
Skin hydration measured using stratum corneum capacitance at affected skin sites.
Measured: Baseline (Day 1), Day 7, and Day 14
Transepidermal Water Loss (TEWL)
Skin barrier function assessed by measuring transepidermal water loss (g/m²/h) using a closed-chamber evaporimeter.
Measured: Baseline (Day 1), Day 7, and Day 14
Skin pH
Skin surface pH measured at affected skin sites using a flat-surface electrode device.
Measured: Baseline (Day 1), Day 7, and Day 14
Skin Temperature
Skin temperature measured at affected skin sites using a skin assessment device.
Measured: Baseline (Day 1), Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jan 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Incontinence-Associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan Armed Forces General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Po Jen Hsiao, MD, PhD, Principal investigator, Taoyuan Armed Forces General HospitalHsieh Chih Tsai, PhD, Study chair, National Taiwan University of Science and TechnologyPo Chung Chen, MD, MS, Study director, Taoyuan Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637695
- Sponsor's protocol ID
- TYAFGH-D-112032
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent and ethics approval did not include provisions for public data sharing. Data contain potentially identifiable information from residents of a long-term care facility, and sharing is restricted to protect participant privacy and confidentiality.
Publications
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.
PubMed 26634182Holroyd 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.
PubMed 25478854McNichol 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.
PubMed 30303813Van 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.
PubMed 29797507
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07637695
- Acronym / sponsor ID
- TYAFGH-D-112032
- Keywords
- incontinence-associated dermatitis, silicone spray, skin barrier, nursing care, long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taoyuan Armed Forces General HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silicone Barrier Spray | Experimental | Device: Silicone Barrier SprayParticipants received a silicone-based barrier spray after structured skin cleansing and moisturizing care throughout the 14-day study period. |
| Zinc Oxide Ointment | Active comparator | Drug: Zinc Oxide OintmentParticipants received zinc oxide ointment after structured skin cleansing and moisturizing care throughout the 14-day study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone Barrier SprayA 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. | Device | Silicone Barrier Spray |
| Zinc Oxide OintmentA 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. | Drug | Zinc Oxide Ointment |
Primary outcome
Change in Incontinence-Associated Dermatitis Severity Score
Time frame: 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.
4 secondary outcomes
Skin Hydration
Time frame: Baseline (Day 1), Day 7, and Day 14
Transepidermal Water Loss (TEWL)
Time frame: Baseline (Day 1), Day 7, and Day 14
Skin pH
Time frame: Baseline (Day 1), Day 7, and Day 14
Skin Temperature
Time frame: Baseline (Day 1), Day 7, and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 26634182Bernatchez 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.
- Results publication: PubMed 25478854Holroyd 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.
- Results publication: PubMed 30303813McNichol 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.
- Results publication: PubMed 29797507Van 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.
- Manufacturer information for Brava Skin Barrier Spray used in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent and ethics approval did not include provisions for public data sharing. Data contain potentially identifiable information from residents of a long-term care facility, and sharing is restricted to protect participant privacy and confidentiality.
Related trials for Incontinence-Associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Moisture Associated Skin Damage, Incontinence Associated Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
Moisture Associated Skin Damage, Fecal Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po Jen Hsiao, MD, PhD principal investigator
Taoyuan Armed Forces General Hospital
Hsieh Chih Tsai, PhD study chair
National Taiwan University of Science and Technology
Po Chung Chen, MD, MS study director
Taoyuan Armed Forces General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Barrier Spray and Zinc Oxide Ointment in people with Incontinence-Associated Dermatitis and Dermatitis, run by Taoyuan Armed Forces General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incontinence-Associated Dermatitis Severity Score (time frame: Baseline (Day 1), Day 7, and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07637695, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.