Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home

NCT07848685 | Completed

• 1 other identifier: KSAFH-RET-2024-559
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure ulcers remain a significant healthcare burden in community and home care settings, particularly among immobile patients. Effective prevention strategies require caregiver education and implementation of evidence-based care bundles. The SSKIN care bundle (Surface, Skin inspection, Keep moving, Incontinence management, Nutrition) is an internationally recognized approach, but its effectiveness when implemented by informal home caregivers using culturally adapted materials remains unclear. This study aimed to compare the knowledge and competency of informal caregivers who received structured training on the SSKIN care bundle versus those receiving traditional verbal instructions, and to evaluate the impact of this training on the incidence of pressure ulcer development in community-dwelling patients at risk for pressure ulcers. Eligible patients were ≥18 years old, at risk for pressure ulcers due to limited mobility (bed-bound or requiring mechanical assistance for repositioning), able to provide informed consent, and receiving home health care services. Eligible caregivers were informal or hired caregivers responsible for daily patient care. Primary outcomes included the caregivers' knowledge of pressure ulcer prevention, assessed via pre-test and post-test questionnaires and the incidence of new pressure ulcers developed during the 6-month follow-up period. Secondary outcome was the mortality rate during the study period.

Conditions

Pressure Ulcer (PU); Pressure Injury; Wounds and Injuries

Keywords

Pressure ulcer prevention; Pressure injury prevention; Caregiver education; Home care; Structured skin care bundle; Skin assessment; Repositioning strategies; Home health services; Bed-bound patients

Outcome Measures

Primary Outcomes (2)

• Change in Caregiver Knowledge Scores on Pressure Ulcer Prevention Questionnaire

  Caregivers' knowledge assessed using a structured 10-point questionnaire covering risk factors, positioning, skin inspection, incontinence management, and nutrition. Pre-test at baseline; post-test at 6 months. The total questionnaire score ranges from 0 to 10, with higher scores indicating greater knowledge. Primary outcome: difference in post-test scores between intervention and control at 6 months.

  At baseline (pre-test) and at 6 months post-enrollment (post-test)

• Incidence of New Pressure Ulcers During 6-Month Community Home Care

  Proportion of patients developing new pressure ulcers (defined as ulcers developing after enrollment or additional ulcers in those with baseline ulcers). Patients will undergo comprehensive skin examinations at baseline and at 1-, 2-, 3-, and 6-month follow-up visits. Outcome: The percentage per group demonstrating intervention effectiveness in preventing new pressure ulcer development in home care.

  During 6-month study period; assessed at baseline, 1-month, 2-month, 3-month, and 6-month follow-up visits

Secondary Outcomes (1)

• All-Cause Mortality During 6-Month Study Period

  Throughout entire 6-month study period; assessed at baseline, 1-month, 2-month, 3-month, and 6-month follow-up visits

Study Arms (2)

Structured SSKIN Care Bundle Training Program

EXPERIMENTAL

Caregivers (n=53) received structured formal training on the SSKIN care bundle (Surface, Skin Inspection, Keep Moving, Incontinence Management, Nutrition) using professionally translated Arabic illustrated materials and culturally adapted content. Educational resources included printed posters, illustrated materials, and implementation checklists in both digital (Google Form/WhatsApp) and printed formats. Training focused on practical, evidence-based pressure ulcer prevention strategies for immobile patients in home care settings.

Behavioral: Structured SSKIN Bundle Caregiver Training Program

Control - Traditional Verbal Instructions

ACTIVE COMPARATOR

Caregivers (n=53) received traditional verbal instructions for pressure ulcer prevention from health workers during routine home care visits, representing standard practice without structured training, formal educational materials, or supplementary resources. No written guidelines, illustrated materials, checklists, or other educational resources were provided. This arm allows comparison of structured training versus standard verbal instruction on caregiver knowledge and patient pressure ulcer outcomes.

Behavioral: Routine Verbal Instruction on Pressure Ulcer Prevention

Interventions

Structured SSKIN Bundle Caregiver Training Program BEHAVIORAL

A comprehensive structured educational training program to enhance caregiver knowledge and competency in pressure ulcer prevention through instruction on the SSKIN care bundle (Surface, Skin Inspection, Keep Moving, Incontinence Management, Nutrition). Training materials were professionally translated to Arabic and culturally adapted for non-healthcare specialist caregivers. Components included: formal in-person training, printed educational posters and illustrated materials, digital and hard-copy implementation checklists, simplified language, and culturally appropriate content. Distinguishing features: structured curriculum format, culturally-tailored materials, accessibility for diverse literacy levels, both digital and analog resource formats. Focus: improving caregiver knowledge, competency, and practical implementation of evidence-based pressure ulcer prevention in home care settings.

Structured SSKIN Care Bundle Training Program

Routine Verbal Instruction on Pressure Ulcer Prevention BEHAVIORAL

Standard verbal instruction on pressure ulcer prevention provided by health workers during routine home health care visits, representing conventional practice in community home care. Instruction was delivered informally during patient encounters without structured curriculum, formal training, or supplementary educational materials. Content varies by health worker judgment and availability, typically including general guidance on skin care, positioning, monitoring, and seeking help for skin concerns. Distinguishing features: informal delivery, variable content, lack of written materials, integration into routine care, non-standardized format.

Control - Traditional Verbal Instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Patients:
• + years old at enrollment
• At risk for pressure ulcers (limited mobility: bed-bound OR dependent on assistance)
• Receiving community home health care services
• Able/willing to provide informed consent (or legal representative)
• Able to attend follow-up visits (baseline, 1m, 2m, 3m, 6m)
• Has a caregiver willing to participate
• For Caregivers:
• + years old at enrollment
• Primary person responsible for patient's daily care
• Family member, informal, or hired caregiver
• Able to understand study language (Arabic/English)
• Willing to participate in assigned intervention
• Able/willing to provide informed consent
• Willing to complete assessments

You may not qualify if:

• For Patients:
• Under 18 years old
• No limited mobility/pressure ulcer risk (fully ambulatory)
• Unable to consent
• Family refuses participation
• In institutional setting (hospital/nursing home)
• Expected discharge within 6 months
• Enrolled in another PU prevention trial
• For Caregivers:
• Under 18 years old
• Unable to consent
• Unable/unwilling to participate in intervention
• Unable to speak study language
• Plans to leave area/stop caring within 6 months
• Healthcare professional (rather than informal/hired caregiver)

Sponsors & Collaborators

• Hiba Hussein, MD: lead

Study Sites (1)

King Salman Armed Forces Hospital in Northwestern Region

Tabuk, Northwestern Region, Saudi Arabia

Location

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 30, 2026
• Study Start: May 10, 2024
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available 12-24 months after publication
• Access Criteria: Data will be made available for researchers and academics upon reasonable request, via direct contact with the corresponding author. This data is intended for use in meta-analyses and systematic reviews, educational research, or health services research.

Locations

SA (1)