NCT06621966

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

September 30, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

Olive oil, Pressure injury, mobility limitations, United Arab Emirates

Outcome Measures

Primary Outcomes (1)

  • Change Pressure Ulcer incidence at 6 Months

    6 months

Study Arms (1)

experimental

EXPERIMENTAL
Other: Olive Oil Topical Oil

Interventions

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.

experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unwilling to participate,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAKMHSU

Ras al-Khaimah, United Arab Emirates

Location

Related Links

MeSH Terms

Conditions

Pressure UlcerMobility Limitation

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 1, 2024

Study Start

January 10, 2024

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations