Clinical trial NCT01595347: Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care
Official title: Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
Primary Prevention
Fatty Acids
Vegetable Fats
Olive oil
"Pressure Ulcer[prevention and control]"[Mesh]
Lead sponsor: Andaluz Health Service
Sponsor class: OTHER_GOV
First posted: 2012-05-10
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Appearance grade II pressure ulcers
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Distrito Sanitario Málaga. Servicio Andaluz de Salud
Study officials:
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Inmaculada Lupiáñez-Pérez, Enfermera
role: STUDY_CHAIR
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Leovigildo Ginel-Mendoza, Medico
role: PRINCIPAL_INVESTIGATOR
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Francisco Javier Navarro-Moya, Enfermero
role: PRINCIPAL_INVESTIGATOR
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Francisco Javier Martín-Santos, Enfermero
role: PRINCIPAL_INVESTIGATOR
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Rafaela Sepúlveda-Guerra, Enfermera
role: PRINCIPAL_INVESTIGATOR
affiliation: Distrito Sanitario Málaga. Servicio Andaluz de Salud
name: Rosa Vázquez-Cerdeiros, Enfermera
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.