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.
RCT Entities:
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.
Authors: Carol Dealey; C Tod Brindle; Joyce Black; Paulo Alves; Nick Santamaria; Evan Call; Michael Clark Journal: Int Wound J Date: 2013-06-20 Impact factor: 3.315
Authors: Inmaculada Lupiañez-Perez; Shakira Kaknani Uttumchandani; Juan Carlos Morilla-Herrera; Francisco Javier Martin-Santos; Magdalena Cuevas Fernandez-Gallego; Francisco Javier Navarro-Moya; Yolanda Lupiañez-Perez; Eugenio Contreras-Fernandez; Jose Miguel Morales-Asencio Journal: PLoS One Date: 2015-04-17 Impact factor: 3.240
Authors: Inmaculada Lupiáñez-Pérez; Juan Carlos Morilla-Herrera; Leovigildo Ginel-Mendoza; Francisco Javier Martín-Santos; Francisco Javier Navarro-Moya; Rafaela Pilar Sepúlveda-Guerra; Rosa Vázquez-Cerdeiros; Magdalena Cuevas-Fernández-Gallego; Isabel María Benítez-Serrano; Yolanda Lupiáñez-Pérez; José Miguel Morales-Asencio Journal: Trials Date: 2013-10-23 Impact factor: 2.279