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
Lupiáñez-Pérez I, Morilla-Herrera JC, Ginel-Mendoza L, Martín-Santos FJ, Navarro-Moya FJ, Sepúlveda-Guerra RP, Vázquez-Cerdeiros R, Cuevas-Fernández-Gallego M, Benítez-Serrano IM, Lupiáñez-Pérez Y, Morales-Asencio JM
Trials · 19 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Ministerio de Sanidad, Política Social e Igualdad
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2013-01-01 · Trials · vol. 14 · número 1 · pág. 348
- Editorial
- Springer Science+Business Media
- Citado
- 32 citas · más que el 94% de estudios similares · 5.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Pressure Ulcer Prevention and Management · Wound Healing and Treatments · Diabetic Foot Ulcer Assessment and Management
- Palabras clave
- pressure ulcer prevention, olive oil, immobilized patients, older adults, home care, primary care, cost-effectiveness, non-inferiority, caregiver support
- MeSH
- humans, fatty acids, plant oils, treatment outcome, clinical protocols, multivariate analysis, logistic models, immobilization, research design, time factors, cost-benefit analysis, drug costs, primary health care, spain, pressure ulcer, olive oil
11 autores
- Inmaculada Lupiáñez‐Pérez🇪🇸 · autor de correspondenciaAndalusian Health Service
- Juan Carlos Morilla Herrera🇪🇸Andalusian Health Service
- Leovigildo Ginel-Mendoza🇪🇸Andalusian Health Service
- Francisco Javier Martín‐Santos🇪🇸Andalusian Health Service
- Francisco Javier Navarro-Moya🇪🇸Andalusian Health Service
- Rafaela Sepúlveda-Guerra🇪🇸Andalusian Health Service
- Rosa Vázquez-Cerdeiros🇪🇸Andalusian Health Service
- Magdalena Cuevas Fernández‐Gallego🇪🇸Andalusian Health Service
- Isabel Benítez-Serrano🇪🇸Andalusian Health Service
- Yolanda Lupiañez-Perez🇪🇸 · autor de correspondenciaHospital Regional Universitario de Málaga; Hospital Clínico Universitario Virgen de la Victoria
- José Miguel Morales‐Asencio🇪🇸Universidad de Málaga
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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