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ENROLLING BY INVITATION
NCT07851519
NA

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.

Sponsor: United Christian Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

65 Days - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-07-20

Completion Date

2026-11-30

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

OTHER

Usual Care

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.

OTHER

Intervention Group

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.

Locations (1)

United Christian Hospital

Hong Kong, Hong Kong