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OpenTrials
Enrolling by Invitation

NCT Number: NCT06621966

Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries

Pressure injuries (PIs) pose significant public health concerns, particularly for hospitalized patients with limited mobility. They are one of the five most common causes of harm in healthcare settings, with a global prevalence ranging from 0% to 72.5%. Hospitalized patients face a higher risk of developing PIs compared to those in community settings, with older adults (over 65 years) being particularly vulnerable.

Meta-analysis reveals a global prevalence of PIs at 14.8%, varying significantly across care settings. For instance, in acute care environments, the prevalence ranges from 6% to 18%, highlighting the need for improved preventive measures. A study in the UAE demonstrated that implementing a new intervention protocol reduced the prevalence of PIs from 2% in 2013 to 1.8% in 2018, underscoring that prevention is less costly than treatment.

Furthermore, research indicates that maintaining skin integrity is crucial in preventing PIs, with the Agency for Healthcare Research and Quality emphasizing the use of "Care Bundles" that include comprehensive skin assessments. Topical emollients and products containing hyper-oxygenated fatty acids (HOFAs) are recommended for enhancing skin hydration and reducing PI risk.

Evidence from studies in Gulf countries shows the effectiveness of olive oil in preventing and treating PIs. Despite existing interventions, recent data from the hospital conducting this study revealed a rising incidence of PIs, from 40 cases in 2020 to 55 cases in 2021. This research aims to evaluate the effectiveness of applying extra virgin olive oil topically, alongside standard preventive measures, to reduce the risk of PIs in mobility-compromised patients.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAKMHSU

Ras al-Khaimah, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • mobility-limited stroke, spinal cord injuries, fractures, multiple sclerosis

Exclusion criteria

unwilling to participate,

Treatment and study plan

Olive Oil Topical Oil

Other

The IVG will receive standard PI prevention care along with a topical application of olive oil for 7 consecutive days. PI point prevalence and baseline risk assessments will be performed prior to the intervention. Post-intervention assessments will be conducted from days 3 to 8. Descriptive statistics and paired sample t-tests will be utilized for data analysis.

Primary outcomes

  1. Change Pressure Ulcer incidence at 6 Months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

RAK Medical and Health Sciences University

Other

Registry information

Official study title

Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries Among Hospitalized Patients With Mobility Limitations: A Cluster Randomized Trial in the United Arab Emirates

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 3, 2024

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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