NCT01595347: PrevenUP

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

Status unknown Phase 4 Last updated 8 May 2012

What this trial tests

Phase 4 trial testing Hyper-oxigenated fatty acid in Pressure Ulcer in 410 participants. Status unknown.

Timeline

1 January 2012

Primary endpoint
1 September 2013

1 January 2014

Quick facts

Lead sponsor	Andaluz Health Service
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	410
Start date	1 January 2012
Primary completion	1 September 2013
Estimated completion	1 January 2014
Sites	1 location across Spain

Drugs / interventions tested

• Hyper-oxigenated fatty acid — full drug profile →
• Olive oil's cream

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

Andaluz Health Service — full company profile →

Who can join

18 and older, any sex, with Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Appearance grade II pressure ulcers
  Time frame: 48 months
  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).

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Lupiañez-Perez I, Uttumchandani SK, Morilla-Herrera JC, Martin-Santos FJ, et al · · 2015 · cited 20× · PMID 25886152 · DOI 10.1371/journal.pone.0122238
2. 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.
   Lupiáñez-Pérez I, Morilla-Herrera JC, Ginel-Mendoza L, Martín-Santos FJ, et al · · 2013 · cited 18× · PMID 24152576 · DOI 10.1186/1745-6215-14-348
3. Dressings and topical agents for preventing pressure ulcers.
   Patton D, Moore ZE, Boland F, Chaboyer WP, et al · · 2024 · cited 5× · PMID 39625073 · DOI 10.1002/14651858.cd009362.pub4
4. 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.
   Lupiañez-Pérez I, Morilla-Herrera JC, Kaknani-Uttumchandani S, Lupiañez-Perez Y, et al · · 2017 · cited 4× · PMID 28922519 · DOI 10.1111/wrr.12586