- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595347
Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care (PrevenUP)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Málaga, Spain, 29009
- Distrito Sanitario Málaga. Servicio Andaluz de Salud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas
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EXPERIMENTAL: Olive oil's Cream
Cream with 60% extra virgin olive oil.
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Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appearance grade II pressure ulcers
Time Frame: 48 months
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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).
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48 months
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Collaborators and Investigators
Sponsor
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
General Publications
- Lupianez-Perez I, Morilla-Herrera JC, Kaknani-Uttumchandani S, Lupianez-Perez Y, Cuevas-Fernandez-Gallego M, Martin-Santos F, Caro-Bautista J, Morales-Asencio JM. A cost minimization analysis of olive oil vs. hyperoxygenated fatty acid treatment for the prevention of pressure ulcers in primary healthcare: A randomized controlled trial. Wound Repair Regen. 2017 Sep;25(5):846-851. doi: 10.1111/wrr.12586. Epub 2017 Nov 6.
- Lupianez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, Fernandez-Gallego MC, Navarro-Moya FJ, Lupianez-Perez Y, Contreras-Fernandez E, Morales-Asencio JM. Topical olive oil is not inferior to hyperoxygenated fatty aids to prevent pressure ulcers in high-risk immobilised patients in home care. Results of a multicentre randomised triple-blind controlled non-inferiority trial. PLoS One. 2015 Apr 17;10(4):e0122238. doi: 10.1371/journal.pone.0122238. eCollection 2015.
- Lupianez-Perez I, Morilla-Herrera JC, Ginel-Mendoza L, Martin-Santos FJ, Navarro-Moya FJ, Sepulveda-Guerra RP, Vazquez-Cerdeiros R, Cuevas-Fernandez-Gallego M, Benitez-Serrano IM, Lupianez-Perez Y, Morales-Asencio JM. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial. Trials. 2013 Oct 23;14:348. doi: 10.1186/1745-6215-14-348.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSM-SAS-2012-1
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