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

Primary Purpose

Pressure Ulcer

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hyper-oxigenated fatty acid
Olive oil's cream
Sponsored by
Andaluz Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure Ulcer, Primary Prevention, Fatty Acids, Vegetable Fats, Olive oil, "Pressure Ulcer[prevention and control]"[Mesh]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Distrito Sanitario Málaga. Servicio Andaluz de Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hyper-oxigenated fatty acid

Olive oil's Cream

Arm Description

Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum

Cream with 60% extra virgin olive oil.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 10, 2012
Last Updated
May 8, 2012
Sponsor
Andaluz Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT01595347
Brief Title
Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care
Acronym
PrevenUP
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andaluz Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Pressure Ulcer, Primary Prevention, Fatty Acids, Vegetable Fats, Olive oil, "Pressure Ulcer[prevention and control]"[Mesh]

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyper-oxigenated fatty acid
Arm Type
Active Comparator
Arm Description
Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum
Arm Title
Olive oil's Cream
Arm Type
Experimental
Arm Description
Cream with 60% extra virgin olive oil.
Intervention Type
Drug
Intervention Name(s)
Hyper-oxigenated fatty acid
Intervention Description
Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas
Intervention Type
Other
Intervention Name(s)
Olive oil's cream
Intervention Description
Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours
Primary Outcome Measure Information:
Title
Appearance grade II pressure ulcers
Description
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).
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Lupiáñez-Pérez, Enfermera
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leovigildo Ginel-Mendoza, Medico
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Javier Navarro-Moya, Enfermero
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martín-Santos, Enfermero
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafaela Sepúlveda-Guerra, Enfermera
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa Vázquez-Cerdeiros, Enfermera
Organizational Affiliation
Distrito Sanitario Málaga. Servicio Andaluz de Salud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Distrito Sanitario Málaga. Servicio Andaluz de Salud
City
Málaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28922519
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.
Results Reference
derived
PubMed Identifier
25886152
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.
Results Reference
derived
PubMed Identifier
24152576
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.
Results Reference
derived

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

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