NCT01595347

Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care

Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Andaluz Health Service · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. AIMS: 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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-09-01
• Completion: 2014-01-01
• First posted: 2012-05-10
• Last updated: 2012-05-10

Locations

1 site across 1 country: Spain