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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01595347
Acronym
PrevenUP
Enrollment
410
Registered
2012-05-10
Start date
2012-01-31
Completion date
2014-01-31
Last updated
2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer, Primary Prevention, Fatty Acids, Vegetable Fats, Olive oil, Pressure Ulcer[prevention and control][Mesh]

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.

Interventions

DRUGHyper-oxigenated fatty acid

Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas

OTHEROlive 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

Sponsors

Andaluz Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Appearance grade II pressure ulcers48 monthsThe 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026