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 |
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| Authors: | Inmaculada Lupia?ez-Perez Shakira Kaknani Uttumchandani Juan Carlos Morilla-Herrera Francisco Javier Martin-Santos Magdalena Cuevas Fernandez-Gallego Francisco Javier Navarro-Moya Yolanda Lupia?ez-Perez Eugenio Contreras-Fernandez Jose Miguel Morales-Asencio |
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| Institution: | 1. Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.; 2. Faculty of Health Sciences, University of Malaga, Malaga, Spain.; 3. Virgen de la Victoria University Hospital and Carlos Haya Regional Hospital, Andalusian Health Service, Malaga, Spain.; 4. Costa del Sol Primary Healthcare District, Andalusian Health Service, Malaga, Spain.; Weill Cornell Medical College Qatar, QATAR, |
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| 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 |
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