RT Journal Article
T1 Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.
A1 Lupiáñez-Pérez, Inmaculada
A1 Morilla-Herrera, Juan Carlos
A1 Ginel-Mendoza, Leovigildo
A1 Martín-Santos, Francisco Javier
A1 Navarro-Moya, Francisco Javier
A1 Sepúlveda-Guerra, Rafaela Pilar
A1 Vázquez-Cerdeiros, Rosa
A1 Cuevas-Fernández-Gallego, Magdalena
A1 Benítez-Serrano, Isabel María
A1 Lupiáñez-Pérez, Yolanda
A1 Morales-Asencio, José Miguel
K1 Hyperoxygenated fatty acids
K1 Olive oil
K1 Pressure ulcers
K1 Prevention
K1 Úlcera por presión
K1 Atención primaria de salud
K1 Cuidados de la piel
K1 Aceite de oliva
K1 Anciano
AB BACKGROUNDPressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment.METHODS/DESIGNThe main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis.DISCUSSIONThe regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment.TRIAL REGISTRATIONClinicaltrials.gov identifier: NCT01595347.
PB BioMed Central
YR 2013
FD 2013-10
LK http://hdl.handle.net/10668/1895
UL http://hdl.handle.net/10668/1895
LA en
NO Lupiáñez-Pérez I, Morilla-Herrera JC, Ginel-Mendoza L, Martín-Santos FJ, Navarro-Moya FJ, Sepúlveda-Guerra RP, et al. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial. Trials. 2013; 14(1):348
NO Journal Article; Research Support, Non-U.S. Gov't;
DS RISalud
RD Mar 17, 2025