Disability PhysicalNCT06621966
Effectiveness of Topical Application of Olive Oil in Preventing Pressure Injuries
A study testing Olive Oil Topical Oil in people with Disability Physical, run by RAK Medical and Health Sciences University at 1 site in United Arab Emirates.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability Physical
- What is being tested?
- Olive Oil Topical Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Jan 2024to 1 Sep 2025
- 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
- mobility-limited stroke, spinal cord injuries, fractures, multiple sclerosis
Who cannot join
- unwilling to participate,
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Disability Physical
- Being tested
- Olive Oil Topical Oil
- Keywords
- Olive oil, Pressure injury, mobility limitations, United Arab Emirates
- Medical subject headings
- Pressure Ulcer, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil Topical OilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Other: Olive Oil Topical Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Pressure Ulcer incidence at 6 Months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Jan 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAK Medical and Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Gamal, RAK Medical and Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621966
- Sponsor's protocol ID
- RAKMHSU-REC-109-2021/2022-PG-N
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06621966
- Acronym / sponsor ID
- RAKMHSU-REC-109-2021/2022-PG-N
- Conditions
- Disability Physical
- Keywords
- Olive oil, Pressure injury, mobility limitations, United Arab Emirates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RAK Medical and Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Oct 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Olive Oil Topical Oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mobility-limited stroke, spinal cord injuries, fractures, multiple sclerosis
Key exclusion criteria (1 listed)
- unwilling to participate,
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 |
|---|---|---|
| Olive Oil Topical OilThe 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. | Other | experimental |
Primary outcome
Change Pressure Ulcer incidence at 6 Months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Olive Oil Topical Oil in people with Disability Physical, run by RAK Medical and Health Sciences University at 1 site in United Arab Emirates.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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 United Arab Emirates. 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?
Results are not available in the source record.
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 Pressure Ulcer incidence at 6 Months (time frame: 6 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 3 Oct 2024.