Abstract
Pressure 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 Design Main 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.DiscussionThe 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
Highlights
Pressure ulcers (PU) provoke healthcare, economic and social problems
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 hyperoxygenated fatty acids (HOFA)
Further studies are needed to investigate the mechanism by which olive oil achieves this outcome
Summary
Pressure ulcers (PU) provoke healthcare, economic and social problems. They produce a significant deterioration in patients’ quality of life [1], with a considerable physical, social, psychological and economic impact and deterioration in overall health, with the consequent reduction in life expectancy. PU represent the alteration of a basic need, that of maintaining the integrity of the skin They can appear anywhere on the body, but are most common on bony prominences (the sacrum, hips and heels), and are suffered by elderly patients who are immobilised with severe acute disease and a neurological deficit. It can lead to necrosis in areas of the epidermis, dermis, subcutaneous tissue and muscle where it is present, and may even affect the joints and bones It tends to occur when the soft tissue is compressed between two planes, one of which is the bony prominence of the patient and the other, an external surface [3].The development of PU is often accompanied by vascular occlusion, due to the external pressure and by endothelial damage affecting microcirculation and the arterioles, primarily due to the effect of tangential forces, shear and friction
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