Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double-blinded clinical trial.

This non-inferiority, multicentre, randomised, controlled, and double-blinded clinical trial compared the therapeutic effectiveness of the topical application of an olive oil solution with that of a hyperoxygenated fatty acid compound for the prevention of pressure ulcers in at-risk nursing home residents. The study population comprised 571 residents of 23 nursing homes with pressure ulcer risk, randomly assigned to a hyperoxygenated fatty acid group (n = 288) or olive oil solution group (n = 283). Both solutions were applied on at-risk skin areas every 12 hours for 30 days or until pressure ulcer onset. The main outcome variable was the pressure ulcer incidence. The absolute risk difference was estimated (with 95% CI) using Kaplan-Meier survival and Cox regression curves. The groups did not significantly differ in any study variable at baseline. The pressure ulcer incidence was 4.18% in the olive oil group vs 6.57% in the control group, with an incidence difference of -2.39% (95% CI = -6.40 to 1.56%), which is within the pre-established non-inferiority margin of ±7%, thus supporting the study hypothesis. We present the first evidence of the effectiveness and safety of the topical application of olive oil to prevent pressure ulcers in the institutionalised elderly.

Eficacia en la prevención de úlceras por presión del aceite de oliva virgen extra frente a los ácidos grasos hiperoxigenados: resultados intermedios de un estudio de no inferioridad / Efficacy for preventing pressure ulcers of the virgin extra olive oil versus hyper-oxygenated fatty acids: intermediate results from a non-inferiority trial

Objetivos: a) Evaluar la eficacia de la aplicación tópica de aceite de oliva virgen extra en la prevención de úlceras por presión (UPP) en pacientes ancianos, en comparación con los ácidos grasos hiperoxigenados (AGHO), medida por la incidencia de UPP. b) Determinar la seguridad terapéutica (efectos adversos) de la aplicación tópica de aceite de oliva virgen extra. La hipótesis por contrastar es que la incidencia de UPP en el grupo tratado con el preparado de aceite de oliva no es superior a la incidencia de UPP en el grupo tratado con AGHO, estableciendo un margen de no inferioridad del 7%. Métodos: ensayo clínico de no inferioridad, multicéntrico, aleatorizado y controlado, con doble enmascaramiento. Se ha incluido a residentes de residencias de mayores en la provincia de Córdoba (España) con riesgo moderado o alto de UPP entre enero de 2011 y abril de 2013. Se excluyeron residentes que ya tenían alguna UPP al inicio, con enfermedad vascular o en situación de gravedad extrema. El tamaño de muestra estimado es de 560 personas, con un muestreo sistemático consecutivo en cada una de las residencias. La intervención testada fue la aplicación cada 12 horas, en zonas de riesgo, de un preparado de aceite oliva virgen extra (Oleicopiel) (grupo experimental) frente a la aplicación de AGHO (Mepentol) (grupo control). Variable principal: incidencia de UPP en cada grupo. Análisis de la diferencia de incidencias entre los dos grupos y tiempo hasta la aparición (análisis de supervivencia). Resultados: datos intermedios sobre una muestra de 247 residentes de 12 residencias. Ambos grupos son equivalentes al inicio. La incidencia de UPP en el grupo del aceite de oliva fue del 7,1% (8 de 112 residentes) y del 6,8% (8 de 117 residentes) en el grupo de AGHO, con una diferencia de incidencias del 0,31% (intervalo de confianza [IC] al 90% = -6,19% a +5,47%) que está dentro del margen de no inferioridad establecido de ±7% y apoya la hipótesis inicial. No se observó ningún efecto adverso en ninguno de los grupos. Conclusiones: se aportan las primeras evidencias sobre la eficacia y seguridad de la aplicación tópica del aceite de oliva virgen extra para prevenir la aparición de UPP en pacientes de residencias de mayores. De acuerdo con estas evidencias es posible afirmar que el producto de aceite de oliva virgen extra es, al menos, igual de eficaz que los AGHO y que, por tanto, es otra opción terapéutica para prevenir las UPP a disposición de los profesionales y los usuarios (AU)

Aims: a) To evaluate the efficacy of topical application of extra virgin olive oil in the prevention of pressure ulcers (PU) in elderly patients compared with hyper-oxygenated fatty acids (HFA), as measured by the incidence of PU. b) To establish the therapeutic safety (adverse effects) of the topical application of extra virgin olive oil. The hypothesis to be tested is that the incidence rate in the group treated with the olive oil shall not exceed the incidence rate in the group treated with HFA, establishing a non-inferiority margin of 7%. Methods: Multicentre, randomized, controlled, double blind, non-inferiority clinical trial. People living in nursing homes in the province of Córdoba (Spain) with moderate or high risk of pressure ulcers have been included. From January 2011 until April 2013. We excluded patients who already had some PU, with vascular disease or in extreme gravity condition. The sample size was estimated in 560 people. Sampling was systematic, enrolling eligible people consecutively in each of the residences. The intervention tested was the application every 12 hours in risk areas, of extra virgin olive oil (Oleicopiel) (experimental group) versus applying hyper-oxygenated fatty acids (Mepentol) (control group). Primary endpoint: incidence of PU in each group. Data analysis: difference in the incidence rates and time to onset (survival analysis). Results: Intermediate data on a sample of 247 patients from 12 nursing homes are reported. Both groups were equivalent at baseline. The PU incidence rate in the olive oil group was 7.1% (8/112 patients) and 6.8% (8/117 patients) in HFA group, with a difference in the incidence rate of 0.31% (90% CI = -6.19% to +5.47%), which is within the non-inferiority margin of ±7% and supports the initial hypothesis. No adverse effect was observed in either group. Conclusions: This paper provides the first evidence on the efficacy and safety of the topical application of extra virgin olive oil to prevent PU in patients at nursing homes. Based on this evidence we can conclude that the product of extra virgin olive oil tested is at least as effective as the HFA, and thus, is another therapeutic option to prevent pressure ulcers available for clinicians and users (AU)