Efectividad de un compuesto de ácidos grasos hiperoxigenados en la prevención de las úlceras por presión / Efficiency of a hyperoxigenated fatty acid compound in the prevention of pressure

Objetivo: Comparar los efectos de Mepentol®, un compuesto de ácidosgrasos hiperoxigenados, frente a placebo en la prevención del desarrollode úlceras por presión. Material y métodos: El estudio de investigaciónconsistió en un ensayo clínico aleatorizado, multicéntrico y dobleciego. Se calculó: la incidencia de úlceras por presión, riesgo relativo(RR), fracción prevenible (FP) y número necesario a tratar (NNT).Además, se aplicaron curvas de supervivencia de Kaplan-Meier conpruebas de log-rank y modelos de riesgos proporcionales de regresión deCox para comparar ambos grupos. Resultados: Completaron el estudioun total de 331 pacientes: 167 en el grupo control y 164 en el grupo aestudio. La incidencia de las úlceras por presión durante el estudio fuede 7,32% en el grupo de intervención frente a 17,37% en el grupo placebo(p= 0,006). Estos resultados muestran que por cada 10 pacientestratados con Mepentol® se previene la aparición de una úlcera por presión(NNT= 9,95). Las curvas de supervivencia y los modelos de regresiónmuestran una diferencia estadísticamente significativa para ambosgrupos (p≤ 0,001). El coste medio del uso de Mepentol® durante elestudio fue de 7,74 €. Conclusión: Mepentol® es una medida efectivapara la prevención de úlceras por presión. Fue más efectiva que un placebograso y demostró ser coste-efectiva. Declaración de interés: elestudio fue esponsorizado por Laboratorios Bama-Geve SA, Barcelona, España

Objective: To compare the effects of Mepentol®, a hyperoxygenated fatty acidpreparation, with a placebo treatment in preventing the development of pressureulcers. Method: The research study consisted of a multicentre double-blindrandomised clinical trial. The incidence of pressure ulcers, relative risk (RR), preventable fraction and number necessary to treat (NNT) were calculated. Inaddition, Kaplan-Meier survival curves, with log-rank test, and Cox’s proportional hazards regression model were used to compare both groups. Results: Atotal of 331 patients completed the study: 167 in the control group and 164in the study group. Pressure-ulcer incidence during the study was 7.32% inthe intervention group versus 17.37% in the placebo group (p= 0,006). Theseresults show that for each 10 patients treated with Mepentol® one pressure ulcerwas prevented (NNT= 9,95). Survival curves and the regression model showeda significant statistical difference for both groups (p≤ 0,001). The averagecost of Mepentol® during the study was € 7,74. Conclusion: Mepentol® is aneffective measure for pressure ulcer prevention. It was more effective than agreasy placebo product, and was found to be cost-effective.Declaration ofinterest: This study was sponsored by Laboratorios Bama-Geve SA,Barcelona, Spain

The effectiveness of a hyperoxygenated fatty acid compound in preventing pressure ulcers.

OBJECTIVE: To compare the effects of Mepentol, a hyperoxygenated fatty acid preparation, with a placebo treatment in preventing the development of pressure ulcers. METHOD: The research study consisted of a multicentre double-blind randomised clinical trial. The incidence of pressure ulcers, relative risk (RR), preventable fraction and number necessary to treat (NNT) were calculated. In addition, Kaplan-Meier survival curves, with log-rank test, and Cox's proportional hazards regression model were used to compare both groups. RESULTS: A total of 331 patients completed the study: 167 in the control group and 164 in the study group. Pressure-ulcer incidence during the study was 7.32% in the intervention group versus 17.37% in the placebo group (p 0.006). These results show that for each 10 patients treated with Mepentol one pressure ulcer was prevented (NNT = 9.95). Survival curves and the regression model showed a significant statistical difference for both groups (p < or = 0.001). The average cost of Mepentol during the study was 7.74 Euro. CONCLUSION: Mepentol is an effective measure for pressure ulcer prevention. It was more effective than a greasy placebo product, and was found to be cost-effective.