Abstract

DIAZ-VALENZUELA, Antonio et al. Efficacy for preventing pressure ulcers of the virgin extra olive oil versus hyper-oxygenated fatty acids: intermediate results from a non-inferiority trial. Gerokomos [online]. 2014, vol.25, n.2, pp.74-80. ISSN 1134-928X.  https://dx.doi.org/10.4321/S1134-928X2014000200005.

Aims: a) To evaluate the efficacy of topical application of extra virgin olive oil in the prevention of pressure ulcers (PU) in elderly patients compared with hyper-oxygenated fatty acids (HFA), as measured by the incidence of PU. b) To establish the therapeutic safety (adverse effects) of the topical application of extra virgin olive oil. The hypothesis to be tested is that the incidence rate in the group treated with the olive oil shall not exceed the incidence rate in the group treated with HFA, establishing a non-inferiority margin of 7%. Methods: Multicentre, randomized, controlled, double blind, non-inferiority clinical trial. People living in nursing homes in the province of Córdoba (Spain) with moderate or high risk of pressure ulcers have been included. From January 2011 until April 2013. We excluded patients who already had some PU, with vascular disease or in extreme gravity condition. The sample size was estimated in 560 people. Sampling was systematic, enrolling eligible people consecutively in each of the residences. The intervention tested was the application every 12 hours in risk areas, of extra virgin olive oil (Oleicopiel) (experimental group) versus applying hyper-oxygenated fatty acids (Mepentol) (control group). Primary endpoint: incidence of PU in each group. Data analysis: difference in the incidence rates and time to onset (survival analysis). Results: Intermediate data on a sample of 247 patients from 12 nursing homes are reported. Both groups were equivalent at baseline. The PU incidence rate in the olive oil group was 7.1% (8/112 patients) and 6.8% (8/117 patients) in HFA group, with a difference in the incidence rate of 0.31% (90% CI = -6.19% to +5.47%), which is within the non-inferiority margin of ±7% and supports the initial hypothesis. No adverse effect was observed in either group. Conclusions: This paper provides the first evidence on the efficacy and safety of the topical application of extra virgin olive oil to prevent PU in patients at nursing homes. Based on this evidence we can conclude that the product of extra virgin olive oil tested is at least as effective as the HFA, and thus, is another therapeutic option to prevent pressure ulcers available for clinicians and users.

Keywords : Pressure ulcers; prevention; hyper-oxigenated fatty acids; olive oil; non-inferiority clinical trial.

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