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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.

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Date

2013-10

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Lupiáñez-Pérez, Inmaculada
Morilla-Herrera, Juan Carlos
Ginel-Mendoza, Leovigildo
Martín-Santos, Francisco Javier
Navarro-Moya, Francisco Javier
Sepúlveda-Guerra, Rafaela Pilar
Vázquez-Cerdeiros, Rosa
Cuevas-Fernández-Gallego, Magdalena
Benítez-Serrano, Isabel María
Lupiáñez-Pérez, Yolanda

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BioMed Central
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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/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.

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Journal Article; Research Support, Non-U.S. Gov't;

MeSH Terms

Medical Subject Headings::Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Skin Ulcer::Pressure Ulcer
Medical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Hygiene::Skin Care
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Aged
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis

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Keywords

Hyperoxygenated fatty acids, Olive oil, Pressure ulcers, Prevention, Úlcera por presión, Atención primaria de salud, Cuidados de la piel, Aceite de oliva, Anciano

Citation

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