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

Pressure Ulcer Clinical Trial

— PrevenUP  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01595347
• Other study ID #: DSM-SAS-2012-1
• Status: Unknown status
• Phase: Phase 4
• First received: January 10, 2012
• Last updated: May 8, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2012
• Source: Andaluz Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 410
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Drug:
• Hyper-oxigenated fatty acid
Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas

Other:
• Olive 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

Locations

Country	Name	City	State
Spain	Distrito Sanitario Málaga. Servicio Andaluz de Salud	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Andaluz Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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