Trial reportPloS one2015
Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.
Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Deterioration of Skin Integrity Subjected to Treatment With Hyperoxygenated Fatty Acids vs Virgin Olive Oil
Who cites it
7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Dressings and topical agents for preventing pressure ulcers.The Cochrane database of systematic reviews · 2024Pooled it
- Efficacy and Safety of Topical Application of Olive Oil for Preventing Pressure Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.International journal of environmental research and public health · 2022Pooled it
- Dressings and topical agents for preventing pressure ulcers.The Cochrane database of systematic reviews · 2018Pooled it
- Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial.International wound journal · 2019Trial
- Evaluation of the effect of fish oil in the prevention of pressure ulcers in patients admitted to the intensive care unit.Contemporary clinical trials communications · 2023Article
- Bioactive Fatty Acids in the Resolution of Chronic Inflammation in Skin Wounds.Advances in wound care · 2020Review
- The Effect of Using Olive Oil and Fish Oil Prophylactic Dressings on Heel Pressure Injury Development in Critically Ill Patients.Clinical, cosmetic and investigational dermatology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledPressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances. METHODS AND
designMain objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers.
resultsThe follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded. DISCUSSION: The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome.
trial registrationClinicaltrials.gov NCT01595347.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.