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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.

dc.contributor.authorLupiáñez-Pérez, Inmaculada
dc.contributor.authorMorilla-Herrera, Juan Carlos
dc.contributor.authorGinel-Mendoza, Leovigildo
dc.contributor.authorMartín-Santos, Francisco Javier
dc.contributor.authorNavarro-Moya, Francisco Javier
dc.contributor.authorSepúlveda-Guerra, Rafaela Pilar
dc.contributor.authorVázquez-Cerdeiros, Rosa
dc.contributor.authorCuevas-Fernández-Gallego, Magdalena
dc.contributor.authorBenítez-Serrano, Isabel María
dc.contributor.authorLupiáñez-Pérez, Yolanda
dc.contributor.authorMorales-Asencio, José Miguel
dc.contributor.authoraffiliation[Lupiañez-Pérez,I; Morilla-Herrera,JC; Ginel-Mendoza,L; Martín-Santos,FJ; Navarro-Moya,FJ; Sepúlveda-Guerra,RP; Vázquez-Cerdeiros,R; Cuevas-Fernández-Gallego,M] District of Primary Health Care Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. [Benítez-Serrano,IM] District of Primary Health Care Costa of Sol, Andalusian Health Service, Malaga, Spain. [Lupiañez-Pérez,Y] University Hospital Virgen de la Victoria, Málaga, Spain. [Lupiañez-Pérez,Y] Regional Hospital Carlos Haya, Malaga, Spain. [Morales-Asencio,JM] Faculty of Health Sciences, University of Málaga, Spain.es
dc.contributor.funderThis research has been funded by the Independent Clinical Calls and Proposals managed by the Spanish Ministry of Health, Social Policy and Equality (EC11-526).
dc.date.accessioned2015-05-25T10:19:59Z
dc.date.available2015-05-25T10:19:59Z
dc.date.issued2013-10
dc.descriptionJournal Article; Research Support, Non-U.S. Gov't;es
dc.description.abstractBACKGROUND 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/DESIGN 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. DISCUSSION 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. TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01595347.en
dc.description.versionYeses
dc.identifier.citationLupiáñez-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):348es
dc.identifier.doi10.1186/1745-6215-14-348
dc.identifier.essn1745-6215
dc.identifier.pmcPMC4016603
dc.identifier.pmid24152576
dc.identifier.urihttp://hdl.handle.net/10668/1895
dc.journal.titleTrials
dc.language.isoen
dc.publisherBioMed Centrales
dc.relation.publisherversionhttp://www.trialsjournal.com/content/14/1/348es
dc.rights.accessRightsopen access
dc.subjectHyperoxygenated fatty acidses
dc.subjectOlive oiles
dc.subjectPressure ulcerses
dc.subjectPreventiones
dc.subjectÚlcera por presiónes
dc.subjectAtención primaria de saludes
dc.subjectCuidados de la pieles
dc.subjectAceite de olivaes
dc.subjectAncianoes
dc.subject.meshMedical Subject Headings::Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Skin Ulcer::Pressure Ulceres
dc.subject.meshMedical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Carees
dc.subject.meshMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Hygiene::Skin Carees
dc.subject.meshMedical Subject Headings::Named Groups::Persons::Age Groups::Adult::Agedes
dc.subject.meshMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humanses
dc.subject.meshMedical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysises
dc.titleEffectiveness 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.en
dc.typeresearch article
dc.type.hasVersionVoR
dspace.entity.typePublication

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