title: Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial.
abstract: Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances.
  
  
  METHODS
  Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers.
  
  
  RESULTS
  The follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded.
  
  
  CONCLUSIONS
  The results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01595347.
authors.affiliation: Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Lupiañez-Perez
authors.affiliation: Faculty of Health Sciences, University of Malaga, Malaga, Spain.
authors.forename: Shakira Kaknani
authors.initials: SK
authors.lastname: Uttumchandani
authors.affiliation: Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Morilla-Herrera
authors.affiliation: Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Martin-Santos
authors.affiliation: Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Magdalena Cuevas
authors.initials: MC
authors.lastname: Fernandez-Gallego
authors.affiliation: Malaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Navarro-Moya
authors.affiliation: Virgen de la Victoria University Hospital and Carlos Haya Regional Hospital, Andalusian Health Service, Malaga, Spain.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Lupiañez-Perez
authors.affiliation: Costa del Sol Primary Healthcare District, Andalusian Health Service, Malaga, Spain.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Contreras-Fernandez
authors.affiliation: Faculty of Health Sciences, University of Malaga, Malaga, Spain.
authors.forename: Jose Miguel
authors.initials: JM
authors.lastname: Morales-Asencio
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers; D005227:Fatty Acids / Q000627:therapeutic use*; D005260:Female; D005269:Femur / Q000473:pathology; D005500:Follow-Up Studies; D006365:Heel / Q000473:pathology; D006699:Home Care Services; D006801:Humans; D007103:Immobilization / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D000069463:Olive Oil / Q000627:therapeutic use*; D010361:Patients; D003668:Pressure Ulcer / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011320:Primary Health Care; D012447:Sacrum / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D005227:Fatty Acids; D000069463:Olive Oil