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
Lupiañez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, Fernandez-Gallego MC, Navarro-Moya FJ, Lupiañez-Perez Y, Contreras-Fernandez E, Morales-Asencio JM
PloS one · 21 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
- 2015-04-17 · PLoS One · vol. 10 · número 4 · pág. e0122238
- Editorial
- Public Library of Science
- Citado
- 33 citas · más que el 94% de estudios similares · 4.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 37 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Pressure Ulcer Prevention and Management · Wound Healing and Treatments · Neonatal skin health care
- Palabras clave
- pressure ulcer prevention, home care, non-inferiority, sacrum, heel, trochanter, skin care products, primary care, pressure ulcer incidence, extra virgin olive oil, non-pharmacological prevention, Andalusia
- MeSH
- heel, femur, sacrum, humans, fatty acids, treatment outcome, follow-up studies, immobilization, aged, aged, 80 and over, middle aged, caregivers, patients, home care services, primary health care, pressure ulcer, female, male, olive oil
9 autores
- Inmaculada Lupiáñez‐Pérez🇪🇸 · autor de correspondenciaAndalusian Health Service
- Shakira Kaknani‐Uttumchandani🇪🇸Universidad de Málaga
- Juan Carlos Morilla Herrera🇪🇸Andalusian Health Service
- Francisco Javier Martín‐Santos🇪🇸Andalusian Health Service
- Magdalena Cuevas Fernández‐Gallego🇪🇸Andalusian Health Service
- Francisco Javier Navarro-Moya🇪🇸Andalusian Health Service
- Yolanda Lupiañez-Perez🇪🇸Andalusian Health Service; Hospital Clínico Universitario Virgen de la Victoria
- Eugenio Contreras-Fernández🇪🇸Andalusian Health Service
- José Miguel Morales‐Asencio🇪🇸Universidad de Málaga
Resumen
El texto original del estudio, en el idioma en que se publicó.
Unlabelled
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 and design
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.
Discussion
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.
Trial registration
Clinicaltrials.gov NCT01595347.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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