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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Francisco Javier Navarro Moya, Andaluz Health Service
ClinicalTrials.gov Identifier:
NCT01595347
First received: January 10, 2012
Last updated: May 8, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Pressure Ulcer
Drug: Hyper-oxigenated fatty acid
Other: Olive oil's cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Andaluz Health Service:

Primary Outcome Measures:
  • Appearance grade II pressure ulcers [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 410
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595347

Locations
Spain
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Málaga, Spain, 29009
Sponsors and Collaborators
Andaluz Health Service
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
  More Information

No publications provided by Andaluz Health Service

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Javier Navarro Moya, Effectiveness and Research Unit Coordinator. Distrito Sanitario Málaga., Andaluz Health Service
ClinicalTrials.gov Identifier: NCT01595347     History of Changes
Other Study ID Numbers: DSM-SAS-2012-1
Study First Received: January 10, 2012
Last Updated: May 8, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Andaluz Health Service:
Pressure Ulcer
Primary Prevention
Fatty Acids
Vegetable Fats
Olive oil
"Pressure Ulcer[prevention and control]"[Mesh]

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014