title: 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.
abstract: BACKGROUND
  Pressure 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
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT01595347.
authors.affiliation: District of Primary Health Care Malaga-Guadalhorce, Andalusian Health Service, Malaga, Spain. ilupianezperez@gmail.com.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Lupiáñez-Pérez
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Morilla-Herrera
authors.forename: Leovigildo
authors.initials: L
authors.lastname: Ginel-Mendoza
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Martín-Santos
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Navarro-Moya
authors.forename: Rafaela Pilar
authors.initials: RP
authors.lastname: Sepúlveda-Guerra
authors.forename: Rosa
authors.initials: R
authors.lastname: Vázquez-Cerdeiros
authors.forename: Magdalena
authors.initials: M
authors.lastname: Cuevas-Fernández-Gallego
authors.forename: Isabel María
authors.initials: IM
authors.lastname: Benítez-Serrano
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Lupiáñez-Pérez
authors.forename: José Miguel
authors.initials: JM
authors.lastname: Morales-Asencio
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005227:Fatty Acids / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007103:Immobilization / Q000009:adverse effects*; D016015:Logistic Models; D015999:Multivariate Analysis; D000069463:Olive Oil; D010938:Plant Oils / Q000191:economics / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D011320:Primary Health Care; D012107:Research Design; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005227:Fatty Acids; D000069463:Olive Oil; D010938:Plant Oils