NCT01595347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

January 10, 2012

Last Update Submit

May 8, 2012

Conditions

Pressure Ulcer

Keywords

Pressure UlcerPrimary PreventionFatty AcidsVegetable FatsOlive oil"Pressure Ulcer[prevention and control]"[Mesh]

Outcome Measures

Primary Outcomes (1)

  • Appearance grade II pressure ulcers

    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

Study Arms (2)

Hyper-oxigenated fatty acid

ACTIVE COMPARATOR

Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum

Drug: Hyper-oxigenated fatty acid

Olive oil's Cream

EXPERIMENTAL

Cream with 60% extra virgin olive oil.

Other: Olive oil's cream

Interventions

Hyper-oxigenated fatty acidDRUG

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

Hyper-oxigenated fatty acid
Olive oil's creamOTHER

Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours

Olive oil's Cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Distrito Sanitario Málaga. Servicio Andaluz de Salud

Málaga, Málaga, 29009, Spain

Location

Related Publications (3)

  • 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.

    PMID: 28922519DERIVED

  • 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.

    PMID: 25886152DERIVED

  • 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.

    PMID: 24152576DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Inmaculada Lupiáñez-Pérez, Enfermera

    Distrito Sanitario Málaga. Servicio Andaluz de Salud

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effectiveness and Research Unit Coordinator. Distrito Sanitario Málaga.

Study Record Dates

First Submitted

January 10, 2012

First Posted

May 10, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

May 10, 2012

Record last verified: 2012-01

Locations

ES(1)