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NCT Number: NCT06758674

The Effect of an Training Program for the Prevention of Pressure Ulcers in Bedridden Patients At Home

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Ataturk Training and Research Hospital

Izmir, Karabaglar, 35360, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients who died during the data collection and follow-up process
  • Changed their home/changed caregivers and/or did not speak Turkish

Treatment and study plan

Education

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Izmir Ataturk Training and Research Hospital

Registry information

Official study title

The Effect of the Training Program Given to Bedridden Patients At Home to Prevent Pressure Ulcer Development on Pressure Ulcer Formation

Acronym: no acronym

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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