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

Phase 4

• Conditions: Pressure Ulcer
• Interventions: Drug: Hyper-oxigenated fatty acid; Other: Olive oil's cream

• Registration Number: NCT01595347
• Lead Sponsor: Andaluz Health Service

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-05-08
• Last Update Submitted: 2012-05-08
• Study First Posted: 2012-05-10
• Last Update Posted: 2012-05-10
• Primary Completion: 2013-09
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyper-oxigenated fatty acid	Hyper-oxigenated fatty acid	Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum
Olive oil's Cream	Olive oil's cream	Cream with 60% extra virgin olive oil.

Primary Outcome Measures

Name	Time	Method
Appearance grade II pressure ulcers	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).

Trial Locations

Locations (1)

Distrito Sanitario Málaga. Servicio Andaluz de Salud; 🇪🇸 Málaga, Spain