Pressure InjuryNCT07851519
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.
A study testing Intervention Group in people with Pressure Injury and Pressure Injury Prevention, run by United Christian Hospital at 1 site in Hong Kong.
Trial summary
This pilot study aims to evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries (PIs) in the perineal-sacral area among incontinent inpatients. Read more about this study
- Who is it for?
- Ages 65 days and older
- Conditions the study is for
- Pressure Injury, Pressure Injury Prevention
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 65 years or older.
- Braden Scale total score of 18 or below at admission screening.
- Presence of urinary incontinence, fecal incontinence, or both, requiring napkin use.
- Intact perineal-sacral skin at the time of enrolment.
Who cannot join
- Presence of an indwelling urinary catheter.
- Active diarrhea at the time of screening.
- Documented allergy or sensitivity to skin barrier products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This pilot study aims to evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries (PIs) in the perineal-sacral area among incontinent inpatients. Incontinence leads to prolonged exposure of skin to moisture and irritants, resulting in Incontinence-Associated Dermatitis (IAD) and increased vulnerability to PIs. Currently, barrier products are applied reactively after skin redness appears. The proposed intervention introduces a proactive approach-daily application of barrier spray during routine morning care before visible damage occurs. Forty inpatients aged65 or above will be recruited from an acute medical ward over 12weeks. Participants admitted in weeks1-6 will receive usual care (control), and those in weeks7-12 will receive the proactive protocol (intervention).
Each will be observed for up to14days or until discharge or skin breakdown. The primary outcome is the incidence of new Stage1-2PIs in the perineal-sacral area; secondary outcomes include IAD incidence, nursing compliance, workload, and cost comparisons. This minimal-risk study uses only approved hospital products, follows standard hygiene and safety procedures, and emphasizes proactive prevention to enhance patient outcomes, nursing efficiency, and resource sustainability. Results will guide future large-scale implementation of standardized moisture-care practices.
Read the detailed description
This pilot study will evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries in the perineal-sacral area among older incontinent inpatients in an acute medical ward.
Incontinent inpatients are at increased risk of skin damage in the perineal and sacral regions because repeated exposure to urine, feces, moisture, friction, and irritants may compromise skin integrity. Moisture-associated skin damage and incontinence-associated dermatitis can increase skin vulnerability to pressure and shear forces, contributing to the development of early-stage pressure injuries. In the current ward practice, barrier products are commonly applied after early skin redness or irritation is observed. This study introduces a proactive preventive approach in which a barrier spray is applied routinely before visible skin damage develops.
The study will use a prospective, quasi-experimental, sequential design. A total of 70 participants will be recruited, with approximately 35 participants in the usual-care control phase and 35 participants in the intervention phase. Participants will be recruited from an acute medical ward during two consecutive study phases over a 12-week period. During weeks 1-6, participants will receive usual care. During weeks 7-12, participants will receive the standardized proactive moisture-care protocol. Allocation will be based on the participant's admission period rather than randomization. This time-based design is intended to allow the ward to implement one care approach at a time and reduce cross-contamination between usual care and the intervention.
All enrolled participants will receive standard nursing care for pressure injury prevention, including routine skin assessment, incontinence care, repositioning as clinically indicated, use of pressure-redistribution measures where appropriate, and other usual preventive practices according to ward procedures. A standardized cleansing approach will be used for incontinence episodes in both study groups to reduce variation in routine hygiene care.
In the usual-care phase, skin barrier products will be applied according to current clinical practice, typically in response to observed skin redness, irritation, or other signs of early skin compromise. Product selection and frequency of use will follow usual nursing assessment and clinical judgment.
In the intervention phase, participants will receive proactive application of a silicone-based skin barrier spray to intact at-risk perineal-sacral skin during routine morning incontinence care. The intervention is intended to provide a protective barrier before visible skin breakdown occurs. Nursing staff will be trained on the study procedures, application method, documentation requirements, and skin assessment expectations before implementation of the intervention phase.
Participants will be followed for up to 14 days, until hospital discharge or transfer out of the ward, or until the first occurrence of skin breakdown in the perineal-sacral area, whichever occurs first. Baseline data will include demographic and clinical characteristics relevant to pressure injury risk, such as age, sex, mobility status, incontinence type, baseline skin condition, and Braden Scale score. Daily monitoring will include assessment of perineal-sacral skin condition and documentation of any new pressure injury or incontinence-associated dermatitis. Suspected new skin breakdown will be reviewed by trained members of the research team to support consistent classification.
The primary evaluation will focus on the occurrence of new Stage 1-2 pressure injuries in the perineal-sacral area during the observation period. Additional feasibility and process measures will include occurrence of incontinence-associated dermatitis, nursing compliance with the proactive protocol, nursing workload related to skin and wound care, and consumable cost comparison between the usual-care and intervention phases.
The study intervention involves a hospital-approved barrier product used as part of routine nursing skin care and is considered minimal risk. Participants will continue to receive all clinically necessary care. Skin condition will be monitored regularly, and any suspected adverse skin reaction will lead to discontinuation of the barrier spray and appropriate clinical review. All study data will be coded and handled in accordance with institutional privacy and data protection requirements.
Findings from this pilot study will be used to assess feasibility, preliminary clinical effect, staff compliance, workload implications, and resource use associated with implementing a standardized proactive moisture-care protocol. The results will inform whether a larger-scale study or broader implementation of proactive moisture-care practice is warranted.
- Conditions
- Pressure Injury, Pressure Injury Prevention
- Being tested
- Usual Care, Intervention Group
- Keywords
- Pressure Injury Prevention, Incontinence-Associated Dermatitis, Skin Barrier Spray, Moisture-Care Protocol, Incontinent Care, Nursing Care Protocol
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Standard reactive nursing care involving no-rinse skin cleansing, with skin barrier products (zinc oxide or barrier cream) applied only upon clinical identification of early skin redness or irritation.
Intervention GroupOther
A proactive moisture-care protocol comprising routine no-rinse skin cleansing and once-daily application of a silicone-based skin barrier spray every morning following incontinence care to all intact perineal-sacral skin.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | This arm receives active usual care (standard cleansing + reactive application of barrier creams upon early signs of redness). Receives: Other: Usual Care |
| Intervention Group | Experimental | Standard moisture care protocol with proactive daily application of Skin Barrier spray every morning to intact perineal-sacral skin. Observation lasts up to 14 days, until hospital discharge, or until skin breakdown occurs. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New Stage 1-2 Perineal-Sacral Pressure Injuries
Percentage of participants who develop a new Stage 1 or Stage 2 pressure injury in the perineal-sacral area, classified using the NPIAP Pressure Injury Staging System.
Measured: Up to 14 days (from admission until hospital discharge or first sign of skin breakdown, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start20 Jul 2026
- Primary completion4 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ng Chu Suen, United Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851519
- Sponsor's protocol ID
- CIRB-2026-036-3
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07851519
- Acronym / sponsor ID
- CIRB-2026-036-3
- Conditions
- Pressure Injury, Pressure Injury Prevention
- Keywords
- Pressure Injury Prevention, Incontinence-Associated Dermatitis, Skin Barrier Spray, Moisture-Care Protocol, Incontinent Care, Nursing Care Protocol
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 4 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Oct 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.
This pilot study aims to evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries (PIs) in the perineal-sacral area among incontinent inpatients. Incontinence leads to prolonged exposure of skin to moisture and irritants, resulting in Incontinence-Associated Dermatitis (IAD) and increased vulnerability to PIs. Currently, barrier products are applied reactively after skin redness appears. The proposed intervention introduces a proactive approach-daily application of barrier spray during routine morning care before visible damage occurs. Forty inpatients aged65 or above will be recruited from an acute medical ward over 12weeks. Participants admitted in weeks1-6 will receive usual care (control), and those in weeks7-12 will receive the proactive protocol (intervention).
Each will be observed for up to14days or until discharge or skin breakdown. The primary outcome is the incidence of new Stage1-2PIs in the perineal-sacral area; secondary outcomes include IAD incidence, nursing compliance, workload, and cost comparisons. This minimal-risk study uses only approved hospital products, follows standard hygiene and safety procedures, and emphasizes proactive prevention to enhance patient outcomes, nursing efficiency, and resource sustainability. Results will guide future large-scale implementation of standardized moisture-care practices.
Detailed description
This pilot study will evaluate whether a standardized proactive moisture-care protocol using a silicone-based skin barrier spray can reduce early-stage pressure injuries in the perineal-sacral area among older incontinent inpatients in an acute medical ward.
Incontinent inpatients are at increased risk of skin damage in the perineal and sacral regions because repeated exposure to urine, feces, moisture, friction, and irritants may compromise skin integrity. Moisture-associated skin damage and incontinence-associated dermatitis can increase skin vulnerability to pressure and shear forces, contributing to the development of early-stage pressure injuries. In the current ward practice, barrier products are commonly applied after early skin redness or irritation is observed. This study introduces a proactive preventive approach in which a barrier spray is applied routinely before visible skin damage develops.
The study will use a prospective, quasi-experimental, sequential design. A total of 70 participants will be recruited, with approximately 35 participants in the usual-care control phase and 35 participants in the intervention phase. Participants will be recruited from an acute medical ward during two consecutive study phases over a 12-week period. During weeks 1-6, participants will receive usual care. During weeks 7-12, participants will receive the standardized proactive moisture-care protocol. Allocation will be based on the participant's admission period rather than randomization. This time-based design is intended to allow the ward to implement one care approach at a time and reduce cross-contamination between usual care and the intervention.
All enrolled participants will receive standard nursing care for pressure injury prevention, including routine skin assessment, incontinence care, repositioning as clinically indicated, use of pressure-redistribution measures where appropriate, and other usual preventive practices according to ward procedures. A standardized cleansing approach will be used for incontinence episodes in both study groups to reduce variation in routine hygiene care.
In the usual-care phase, skin barrier products will be applied according to current clinical practice, typically in response to observed skin redness, irritation, or other signs of early skin compromise. Product selection and frequency of use will follow usual nursing assessment and clinical judgment.
In the intervention phase, participants will receive proactive application of a silicone-based skin barrier spray to intact at-risk perineal-sacral skin during routine morning incontinence care. The intervention is intended to provide a protective barrier before visible skin breakdown occurs. Nursing staff will be trained on the study procedures, application method, documentation requirements, and skin assessment expectations before implementation of the intervention phase.
Participants will be followed for up to 14 days, until hospital discharge or transfer out of the ward, or until the first occurrence of skin breakdown in the perineal-sacral area, whichever occurs first. Baseline data will include demographic and clinical characteristics relevant to pressure injury risk, such as age, sex, mobility status, incontinence type, baseline skin condition, and Braden Scale score. Daily monitoring will include assessment of perineal-sacral skin condition and documentation of any new pressure injury or incontinence-associated dermatitis. Suspected new skin breakdown will be reviewed by trained members of the research team to support consistent classification.
The primary evaluation will focus on the occurrence of new Stage 1-2 pressure injuries in the perineal-sacral area during the observation period. Additional feasibility and process measures will include occurrence of incontinence-associated dermatitis, nursing compliance with the proactive protocol, nursing workload related to skin and wound care, and consumable cost comparison between the usual-care and intervention phases.
The study intervention involves a hospital-approved barrier product used as part of routine nursing skin care and is considered minimal risk. Participants will continue to receive all clinically necessary care. Skin condition will be monitored regularly, and any suspected adverse skin reaction will lead to discontinuation of the barrier spray and appropriate clinical review. All study data will be coded and handled in accordance with institutional privacy and data protection requirements.
Findings from this pilot study will be used to assess feasibility, preliminary clinical effect, staff compliance, workload implications, and resource use associated with implementing a standardized proactive moisture-care protocol. The results will inform whether a larger-scale study or broader implementation of proactive moisture-care practice is warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual CareThis arm receives active usual care (standard cleansing + reactive application of barrier creams upon early signs of redness). |
| Intervention Group | Experimental | Other: Intervention GroupStandard moisture care protocol with proactive daily application of Skin Barrier spray every morning to intact perineal-sacral skin. Observation lasts up to 14 days, until hospital discharge, or until skin breakdown occurs. |
Who may qualify
- Ages
- 65 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 65 years or older.
- Braden Scale total score of 18 or below at admission screening.
- Presence of urinary incontinence, fecal incontinence, or both, requiring napkin use.
- Intact perineal-sacral skin at the time of enrolment.
Key exclusion criteria (3 listed)
- Presence of an indwelling urinary catheter.
- Active diarrhea at the time of screening.
- Documented allergy or sensitivity to skin barrier products.
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 |
|---|---|---|
| Usual CareStandard reactive nursing care involving no-rinse skin cleansing, with skin barrier products (zinc oxide or barrier cream) applied only upon clinical identification of early skin redness or irritation. | Other | Usual care |
| Intervention GroupA proactive moisture-care protocol comprising routine no-rinse skin cleansing and once-daily application of a silicone-based skin barrier spray every morning following incontinence care to all intact perineal-sacral skin. | Other | Intervention Group |
Primary outcome
Incidence of New Stage 1-2 Perineal-Sacral Pressure Injuries
Time frame: Up to 14 days (from admission until hospital discharge or first sign of skin breakdown, whichever occurs first)
Percentage of participants who develop a new Stage 1 or Stage 2 pressure injury in the perineal-sacral area, classified using the NPIAP Pressure Injury Staging System.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Pressure Injury and Pressure Injury Prevention, run by United Christian Hospital at 1 site in Hong Kong.
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: enrolling by invitation, as of the sponsor's last update on 7 Oct 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of New Stage 1-2 Perineal-Sacral Pressure Injuries (time frame: Up to 14 days (from admission until hospital discharge or first sign of skin breakdown, whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.