Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care (PrevenUP)
Recruitment status was: Enrolling by invitation
Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).
There do not exist studies realized specifically with cream of olive oil.
Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.
To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.
METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant.
|Pressure Ulcer||Drug: Hyper-oxigenated fatty acid Other: Olive oil's cream||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.|
- Appearance grade II pressure ulcers [ Time Frame: 48 months ]The primary outcome or result is the appearance of grade II pressure ulcers in patients under study during the 9 months follow up. This will be confirmed by observation of the areas where we did the intervention (sacrum, hips and heels).
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Hyper-oxigenated fatty acid
Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum
Drug: Hyper-oxigenated fatty acid
Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas
Experimental: Olive oil's Cream
Cream with 60% extra virgin olive oil.
Other: Olive oil's cream
Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595347
|Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Málaga, Spain, 29009|
|Study Chair:||Inmaculada Lupiáñez-Pérez, Enfermera||Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Principal Investigator:||Leovigildo Ginel-Mendoza, Medico||Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Principal Investigator:||Francisco Javier Navarro-Moya, Enfermero||Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Principal Investigator:||Francisco Javier Martín-Santos, Enfermero||Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Principal Investigator:||Rafaela Sepúlveda-Guerra, Enfermera||Distrito Sanitario Málaga. Servicio Andaluz de Salud|
|Principal Investigator:||Rosa Vázquez-Cerdeiros, Enfermera||Distrito Sanitario Málaga. Servicio Andaluz de Salud|