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
| Autor: | Magdalena Cuevas Fernández-Gallego, Inmaculada Lupiáñez-Pérez, Eugenio Contreras-Fernandez, Juan Carlos Morilla-Herrera, Yolanda Lupiañez-Perez, Shakira Kaknani Uttumchandani, José Miguel Morales-Asencio, Francisco Javier Navarro-Moya, Francisco Javier Martín-Santos |
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| Přispěvatelé: | [Lupiañez-Perez,I, Morilla-Herrera,JC, Martín-Santos,FJ, Fernández-Gallego,MC, Navarro-Moya,FJ] Málaga-Guadalhorce Primary Healthcare District, Andalusian Health Service, Málaga, Spain. [Uttumchandani,SK, Morales-Asencio,JM] Faculty of Health Sciences, University of Málaga, Spain. [Lupiáñez-Pérez,Y] Virgen de la Victoria University Hospital, Carlos Haya Regional Hospital, Andalusian Health Service, Málaga, Spain. [Contreras-Fernández,E] Costa del Sol Primary Healthcare District, Andalusian Health Service, Málaga, Spain., This research was undertaken pursuant to the Independent Clinical Calls and Proposals managed by the Spanish Ministry of Health, Social Policy and Equality (EC11-526). |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Male
España law.invention Úlcera por presión Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] Randomized controlled trial law Epidemiology Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Skin Ulcer::Pressure Ulcer [Medical Subject Headings] Femur Aceites vegetales Ácidos grasos Geographicals::Geographic Locations::Europe::Spain [Medical Subject Headings] Aged 80 and over Pressure Ulcer education.field_of_study Multidisciplinary Incidence (epidemiology) Fatty Acids Chemicals and Drugs::Lipids::Fatty Acids [Medical Subject Headings] Middle Aged Home Care Services Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care [Medical Subject Headings] Humanos Health Care::Health Care Facilities Manpower and Services::Health Services::Community Health Services::Home Care Services [Medical Subject Headings] Treatment Outcome Caregivers Medicine Female Servicios de atención de salud a domicilio Research Article medicine.medical_specialty Sacrum Randomization Patients Science Population Immobilization Atención primaria de salud medicine Humans education Olive Oil Aged Intention-to-treat analysis Primary Health Care business.industry Confidence interval Surgery Clinical trial Chemicals and Drugs::Lipids::Oils::Plant Oils [Medical Subject Headings] Heel business Follow-Up Studies |
| Zdroj: | PLoS ONE PLoS ONE, Vol 10, Iss 4, p e0122238 (2015) |
| ISSN: | 1932-6203 |
| Popis: | UnlabelledPressure 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 and designMain 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.ResultsThe 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.DiscussionThe 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.Trial registrationClinicaltrials.gov NCT01595347. |
| Databáze: | OpenAIRE |
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