Pressure Ulcer Preventionno acronymNCT06758674
The Effect of an Training Program for the Prevention of Pressure Ulcers in Bedridden Patients At Home
A study testing education in people with Pressure Ulcer Prevention, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Pressure ulcers are wounds that typically occur on bony prominences, primarily due to external factors such as pressure, friction, and shear, as well as internal factors related to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Prevention
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being a home care patient who has registered to Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month
- Being over 18 years of age
- Being bedridden
- Not having pressure sores on any part of the body
Who cannot join
- Patients who died during the data collection and follow-up process
- Changed their home/changed caregivers and/or did not speak Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Ataturk Training and Research Hospital
Izmir, Karabaglar, 35360
About this study
Official title: The Effect of the Training Program Given to Bedridden Patients At Home to Prevent Pressure Ulcer Development on Pressure Ulcer Formation
Pressure ulcers are wounds that typically occur on bony prominences, primarily due to external factors such as pressure, friction, and shear, as well as internal factors related to the patient. These ulcers can lead to serious health issues and have a high incidence rate, negatively impacting patients' quality of life, increasing hospitalization duration, and adding to healthcare costs. Prevention of pressure ulcers is considered an important indicator of care quality worldwide and in our country. International guidelines emphasize key points for preventing pressure ulcers, including risk assessment, skin assessment and care, nutrition, repositioning, support surface use, documentation, and education.
Read the detailed description
A pressure ulcer is defined as "localized skin and/or subcutaneous tissue damage caused by pressure alone or in combination with pressure or tearing, usually occurring on bony prominences". Mostly, it develops as a result of prolonged compression of soft tissue between the bony prominence and the outer surface. External factors such as a large force applied for a short period of time or less force applied for a long period of time, friction, tearing, and stretching to which the skin is exposed disrupt the blood flow to the area, prevent oxygen and nutrient transport to the tissues and cause pressure sores. An overly moist environment caused by sweating, urinary or fecal incontinence or excessive wound drainage increases the harmful effects of pressure, friction and shearing. It also causes maceration of the surrounding skin, which combines these factors. Friction and moisture have their greatest effect in areas of high pressure. If moisture is present, the effects of friction increase up to five times. In addition, intrinsic risk factors associated with the development of pressure sores include old age (70 years and older), immobility/impaired mobility, dehydration, impaired sensory perception and tissue perfusion, malnutrition, anemia, low albumin levels, hypothermia, hypotensive episodes, diabetes and peripheral vascular disease, medications that cause vasoconstriction, current smoking history, dry skin, low Body Mass Index, altered mental status (e.g. confusion), urinary and fecal incontinence, physical limitations, malignancy, history of pressure ulcers. Urinary and fecal incontinence, physical limitations, malignancy, history of pressure ulcers. Pressure ulcers, a pathology with high morbidity and mortality, cause a significant increase in caregiver burden and care costs. Treatment of pressure sores ranks third in terms of cost after malignancies and cardiovascular diseases. In a study conducted in nursing homes in the UK, pressure ulcer treatment costs 1.4-2.1 billion pounds per patient. In Turkey, the annual cost is estimated to be $1 billion 425 million. The European Pressure Ulcer Advisory Panel (EPUAP) recommends that identifying pressure ulcers at Stage 1 and preventing complications and deepening by taking effective measures is the most effective way to reduce costs.
Today, guidelines have been developed in the light of evidence-based practices to prevent pressure ulcers. The main prevention interventions included in these guidelines are assessment of pressure ulcer risk, skin assessment and care, assessment and support of nutritional status, changing position, use of support surfaces, education of healthcare professionals, patients and their relatives, and record keeping. The simplest and easiest way to prevent the development of pressure sores is to take prevention measures. The basic approach in the prevention of pressure sores is to evaluate the possible risks to prevent the development of the wound before it occurs, early identification of the risk group and early implementation of prevention initiatives. EPUAP and NPUAP recommend that all bedridden patients with limited mobility should be considered in the risk group. In the light of all this information, in this study, it was aimed to provide training to the caregivers of bedridden patients to prevent pressure ulcers at home in line with the recommendation of the guidelines as one of the effective interventions in the prevention of pressure sores and to examine the effect of this training on pressure ulcer formation.
- Conditions
- Pressure Ulcer Prevention
- Being tested
- education
- Keywords
- pressure ulcer, nurse, prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
Prepared in clear language and supported with visuals in line with guidelines and studies (Kottner et al. 2019, Orhan 2017, APUPA 2011, EPUAP and NPUAP 2009, EPUAP 2019, Arıkan and vanGiersbergen 2019, Arslantaş et al. 2018) training will be given to prevent pressure ulcers. Training content will be sent to expert opinion for content validity. In the content of the training, the definition of pressure ulcers, how they develop, high-risk areas for wound formation, identification of risks, evaluation of the skin, skin care, lying positions and position changes, supporting bone protrusions with pillows, lying on a support surface, nutritional status and content, fluid intake will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients assigned to the experimental group will first be informed about the study by phone and their participation status will be questioned. The relatives of the patients who want to participate in the study will be visited at home with the Home Health Services unit of Izmir Atatürk Training and Research Hospital and the data collection process and training will be carried out. After the training is given, the caregiver will be questioned about the applicability of the training content and the need for reminder training by calling the caregiver weekly in the first month and every two weeks in the second and third months for three months, and will be evaluated in terms of pressure sore formation, primarily in risky areas, during these interviews or by using the records of home health services. Receives: Other: education |
| control group | No intervention | Patients assigned to the control group must be home care patients who have registered with Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month, be over 18 years of age, be bedridden, and not have developed pressure sores on any part of their body. The caregivers of the patients assigned to the control group will be invited to the study by calling by phone, the introductory characteristics of the relatives of the patients who want to participate will be taken first, and the formation of pressure ulcers at the end of the first, second and third month without any training will be evaluated by calling by phone or by using the records of the Home Health Services Unit. At the end of the study, the patient / patient relatives assigned to the control group will also be given training to prevent pressure sores and a brochure will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of pressure injury
Patients will be evaluated for pressure ulcers three months after the end of the training. In patients with pressure ulcers, the site and stage of the wound will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Nov 2024
- Primary completion20 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer PreventionStudies 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
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Ataturk Training and Research Hospital
- Responsible party
- Principal investigator, Aylin Ozcan, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758674
- Sponsor's protocol ID
- IKCU-SBF-AO-01
- Other IDs
- 2024-TYL-SABE-0027
- Acronym
- no acronym
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Program Given to Bedridden Patients At Home to Prevent Pressure Ulcer Development on Pressure Ulcer Formation
- ClinicalTrials.gov ID
- NCT06758674
- Acronym / sponsor ID
- no acronym / IKCU-SBF-AO-01
- Conditions
- Pressure Ulcer Prevention
- Keywords
- pressure ulcer, nurse, prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Izmir Ataturk Training and Research Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 6 Jan 2025 (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 are wounds that typically occur on bony prominences, primarily due to external factors such as pressure, friction, and shear, as well as internal factors related to the patient. These ulcers can lead to serious health issues and have a high incidence rate, negatively impacting patients' quality of life, increasing hospitalization duration, and adding to healthcare costs. Prevention of pressure ulcers is considered an important indicator of care quality worldwide and in our country. International guidelines emphasize key points for preventing pressure ulcers, including risk assessment, skin assessment and care, nutrition, repositioning, support surface use, documentation, and education.
Detailed description
A pressure ulcer is defined as "localized skin and/or subcutaneous tissue damage caused by pressure alone or in combination with pressure or tearing, usually occurring on bony prominences". Mostly, it develops as a result of prolonged compression of soft tissue between the bony prominence and the outer surface. External factors such as a large force applied for a short period of time or less force applied for a long period of time, friction, tearing, and stretching to which the skin is exposed disrupt the blood flow to the area, prevent oxygen and nutrient transport to the tissues and cause pressure sores. An overly moist environment caused by sweating, urinary or fecal incontinence or excessive wound drainage increases the harmful effects of pressure, friction and shearing. It also causes maceration of the surrounding skin, which combines these factors. Friction and moisture have their greatest effect in areas of high pressure. If moisture is present, the effects of friction increase up to five times. In addition, intrinsic risk factors associated with the development of pressure sores include old age (70 years and older), immobility/impaired mobility, dehydration, impaired sensory perception and tissue perfusion, malnutrition, anemia, low albumin levels, hypothermia, hypotensive episodes, diabetes and peripheral vascular disease, medications that cause vasoconstriction, current smoking history, dry skin, low Body Mass Index, altered mental status (e.g. confusion), urinary and fecal incontinence, physical limitations, malignancy, history of pressure ulcers. Urinary and fecal incontinence, physical limitations, malignancy, history of pressure ulcers. Pressure ulcers, a pathology with high morbidity and mortality, cause a significant increase in caregiver burden and care costs. Treatment of pressure sores ranks third in terms of cost after malignancies and cardiovascular diseases. In a study conducted in nursing homes in the UK, pressure ulcer treatment costs 1.4-2.1 billion pounds per patient. In Turkey, the annual cost is estimated to be $1 billion 425 million. The European Pressure Ulcer Advisory Panel (EPUAP) recommends that identifying pressure ulcers at Stage 1 and preventing complications and deepening by taking effective measures is the most effective way to reduce costs.
Today, guidelines have been developed in the light of evidence-based practices to prevent pressure ulcers. The main prevention interventions included in these guidelines are assessment of pressure ulcer risk, skin assessment and care, assessment and support of nutritional status, changing position, use of support surfaces, education of healthcare professionals, patients and their relatives, and record keeping. The simplest and easiest way to prevent the development of pressure sores is to take prevention measures. The basic approach in the prevention of pressure sores is to evaluate the possible risks to prevent the development of the wound before it occurs, early identification of the risk group and early implementation of prevention initiatives. EPUAP and NPUAP recommend that all bedridden patients with limited mobility should be considered in the risk group. In the light of all this information, in this study, it was aimed to provide training to the caregivers of bedridden patients to prevent pressure ulcers at home in line with the recommendation of the guidelines as one of the effective interventions in the prevention of pressure sores and to examine the effect of this training on pressure ulcer formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: educationPatients assigned to the experimental group will first be informed about the study by phone and their participation status will be questioned. The relatives of the patients who want to participate in the study will be visited at home with the Home Health Services unit of Izmir Atatürk Training and Research Hospital and the data collection process and training will be carried out. After the training is given, the caregiver will be questioned about the applicability of the training content and the need for reminder training by calling the caregiver weekly in the first month and every two weeks in the second and third months for three months, and will be evaluated in terms of pressure sore formation, primarily in risky areas, during these interviews or by using the records of home health services. |
| control group | No intervention | –Patients assigned to the control group must be home care patients who have registered with Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month, be over 18 years of age, be bedridden, and not have developed pressure sores on any part of their body. The caregivers of the patients assigned to the control group will be invited to the study by calling by phone, the introductory characteristics of the relatives of the patients who want to participate will be taken first, and the formation of pressure ulcers at the end of the first, second and third month without any training will be evaluated by calling by phone or by using the records of the Home Health Services Unit. At the end of the study, the patient / patient relatives assigned to the control group will also be given training to prevent pressure sores and a brochure will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a home care patient who has registered to Izmir Atatürk Training and Research Hospital Home Health Services Unit within the last month
- Being over 18 years of age
- Being bedridden
- Not having pressure sores on any part of the body
Key exclusion criteria (2 listed)
- Patients who died during the data collection and follow-up process
- Changed their home/changed caregivers and/or did not speak Turkish
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 |
|---|---|---|
| educationPrepared in clear language and supported with visuals in line with guidelines and studies (Kottner et al. 2019, Orhan 2017, APUPA 2011, EPUAP and NPUAP 2009, EPUAP 2019, Arıkan and vanGiersbergen 2019, Arslantaş et al. 2018) training will be given to prevent pressure ulcers. Training content will be sent to expert opinion for content validity. In the content of the training, the definition of pressure ulcers, how they develop, high-risk areas for wound formation, identification of risks, evaluation of the skin, skin care, lying positions and position changes, supporting bone protrusions with pillows, lying on a support surface, nutritional status and content, fluid intake will be discussed. | Other | experimental group |
Primary outcome
occurrence of pressure injury
Time frame: 3 months
Patients will be evaluated for pressure ulcers three months after the end of the training. In patients with pressure ulcers, the site and stage of the wound will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pressure Ulcer Prevention
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruiting
Evaluation of the Effectiveness of Vision Care in Preventing Falls in Hospitalized Patients
Falls, Ulcer, Pressure
Enrolling by invitation
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.
Pressure Injury, Pressure Injury Prevention
Enrolling by invitationObservational study
Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
Pressure Injury Prevention
Not yet recruiting
Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
Pressure Ulcers (Hospital-acquired Pressure Injuries)
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 education in people with Pressure Ulcer Prevention, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
occurrence of pressure injury (time frame: 3 months). 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 6 Jan 2025.