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.

NCT07851519 | Enrolling By Invitation

• 1 other identifier: CIRB-2026-036-3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pressure Injury; Pressure Injury Prevention

Keywords

Pressure Injury Prevention; Incontinence-Associated Dermatitis; Skin Barrier Spray; Moisture-Care Protocol; Incontinent Care; Nursing Care Protocol

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 14 days (from admission until hospital discharge or first sign of skin breakdown, whichever occurs first)

Study Arms (2)

Usual care

ACTIVE COMPARATOR

This arm receives active usual care (standard cleansing + reactive application of barrier creams upon early signs of redness).

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.

Other: Intervention Group

Interventions

Usual Care OTHER

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.

Usual care

Intervention Group OTHER

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Presence of an indwelling urinary catheter.
• Active diarrhea at the time of screening.
• Documented allergy or sensitivity to skin barrier products.

Sponsors & Collaborators

• United Christian Hospital: lead

Study Sites (1)

United Christian Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Nurse

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 4, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)