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Enrolling By Invitation NCT07851519

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.

Conditions: Pressure Injury, Pressure Injury Prevention

Sex: All
Ages: 65 Days – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: United Christian Hospital

Location: United Christian Hospital Hong Kong

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Presence of an indwelling urinary catheter. * Active diarrhea at the time of screening. * Documented allergy or sensitivity to skin barrier products.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07851519). StuddyBuddy aggregates publicly available trial information.