RT Journal Article T1 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. A1 Lupiáñez-Pérez, Inmaculada A1 Uttumchandani, Shakira Kaknani A1 Morilla-Herrera, Juan Carlos A1 Martín-Santos, Francisco Javier A1 Fernández-Gallego, Magdalena Cuevas A1 Navarro-Moya, Francisco Javier A1 Lupiáñez-Pérez, Yolanda A1 Contreras-Fernández, Eugenio A1 Morales-Asencio, José Miguel K1 Úlcera por presión K1 Atención primaria de salud K1 Aceites vegetales K1 Ácidos grasos K1 Humanos K1 España K1 Servicios de atención de salud a domicilio AB 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.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. PB Public Library of Science YR 2015 FD 2015-04-17 LK http://hdl.handle.net/10668/2266 UL http://hdl.handle.net/10668/2266 LA en NO Lupiáñez-Pérez I, Uttumchandani SK, Morilla-Herrera JC, Martín-Santos FJ, Fernández-Gallego MC, Navarro-Moya FJ, et al. 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. PLoS ONE. 2015; 10(4):e0122238 NO Journal Article; DS RISalud RD Apr 11, 2025