Pressure Ulcer (PU)NCT07848685
Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home
A study testing Structured SSKIN Bundle Caregiver Training Program and Routine Verbal Instruction on Pressure Ulcer Prevention in people with Pressure Ulcer (PU) and Pressure Injury, run by Hiba Hussein, MD at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer (PU), Pressure Injury, Wounds and Injuries
- What is being tested?
- Structured SSKIN Bundle Caregiver Training Program and Routine Verbal Instruction on Pressure Ulcer Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 May 2024to 10 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Patients:
- 18+ 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)
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- Has a caregiver willing to participate
- For Caregivers:
- 18+ 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Salman Armed Forces Hospital in Northwestern Region
Tabuk, Northwestern Region
About this study
Official title: Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Structured SSKIN Bundle Caregiver Training Program, Routine Verbal Instruction on Pressure Ulcer Prevention
- 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
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured SSKIN Bundle Caregiver Training ProgramBehavioural
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.
Routine Verbal Instruction on Pressure Ulcer PreventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Verbal Instruction on Pressure Ulcer Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Safety outcome tracking death from any cause during 6-month period to ensure intervention poses no harm. Vital status recorded at each scheduled follow-up visit, and the date of death documented when applicable. The outcome reported as the percentage of patients who die from any cause in each study group.
Measured: Throughout entire 6-month study period; assessed at baseline, 1-month, 2-month, 3-month, and 6-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start10 May 2024
- Primary completion10 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer (PU)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiba Hussein, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hiba Hussein, MD, King Fahad Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848685
- Sponsor's protocol ID
- KSAFH-RET-2024-559
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared including patient demographics (age, sex, marital status), clinical characteristics, knowledge assessment scores (pre/post-test), new pressure ulcer incidence, vital status (alive/deceased), and caregiver data (demographics, education, relationship).
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07848685
- Acronym / sponsor ID
- KSAFH-RET-2024-559
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hiba Hussein, MDOther government
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 30 Sep 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured SSKIN Care Bundle Training Program | Experimental | Behavioral: Structured SSKIN Bundle Caregiver Training ProgramCaregivers (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. |
| Control - Traditional Verbal Instructions | Active comparator | Behavioral: Routine Verbal Instruction on Pressure Ulcer PreventionCaregivers (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18+ 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)
Key exclusion criteria (15 listed)
- Under 18 years old
- No limited mobility/pressure ulcer risk (fully ambulatory)
- Unable to consent
- Family refuses participation
- In institutional setting (hospital/nursing home)
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 |
|---|---|---|
| Structured SSKIN Bundle Caregiver Training ProgramA 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. | Behavioural | Structured SSKIN Care Bundle Training Program |
| Routine Verbal Instruction on Pressure Ulcer PreventionStandard 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. | Behavioural | Control - Traditional Verbal Instructions |
Primary outcome
Change in Caregiver Knowledge Scores on Pressure Ulcer Prevention Questionnaire
Time frame: At baseline (pre-test) and at 6 months post-enrollment (post-test)
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.
Incidence of New Pressure Ulcers During 6-Month Community Home Care
Time frame: During 6-month study period; assessed at baseline, 1-month, 2-month, 3-month, and 6-month follow-up visits
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.
1 secondary outcome
All-Cause Mortality During 6-Month Study Period
Time frame: Throughout entire 6-month study period; assessed at baseline, 1-month, 2-month, 3-month, and 6-month follow-up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared including patient demographics (age, sex, marital status), clinical characteristics, knowledge assessment scores (pre/post-test), new pressure ulcer incidence, vital status (alive/deceased), and caregiver data (demographics, education, relationship).
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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. This study is not recruiting at the moment.
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 Structured SSKIN Bundle Caregiver Training Program and Routine Verbal Instruction on Pressure Ulcer Prevention in people with Pressure Ulcer (PU) and Pressure Injury, run by Hiba Hussein, MD at 1 site in Saudi Arabia.
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 15 inclusion and 15 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: finished, as of the sponsor's last update on 30 Sep 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Caregiver Knowledge Scores on Pressure Ulcer Prevention Questionnaire (time frame: At baseline (pre-test) and at 6 months post-enrollment (post-test)). The study lists 2 primary outcomes in all. 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 30 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.