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

May 8, 2012 updated by: Francisco Javier Navarro Moya, Andaluz Health Service

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Málaga, Spain, 29009
        • Distrito Sanitario Málaga. Servicio Andaluz de Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with nursing diagnosis "risk of impaired skin integrity. "To determine this risk assessment tool we will use as the Braden scale. We will include only patients immobilized with increased risk of pressure ulcers (score less than or equal to 16).
  • Patients with malnutrition or suspected malnutrition. To determine this state as an instrument we will use Mini Nutritional Assessment Scale "MNA" (score 10 points or less)
  • Over 18 years.

Exclusion criteria:

  • Patients refusal to participate in the study.
  • Moved (patient no habitual residence in the health center where they make the study).
  • Patients with plans to be out of the study area during the monitoring year.
  • Hospitalized during the uptake phase of the sample
  • Patient-terminal.
  • Patient with the presence of pressure ulcers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hyper-oxigenated fatty acid
Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum
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.
Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

January 1, 2014

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (ESTIMATE)

May 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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