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

Abstract

Pressure ulcers represent a major current health problem and produce an important economic impact on the healthcare system. Most of studies to prevent pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids and to date, no studies have specifically examined the use of olive oil-based substances.Methods and Design Main objective: To assess the effectiveness of the use of olive oil, comparing it with hyperoxygenated fatty acids, for immobilised home-care patients at risk of suffering pressure ulcers. Design: Non-inferiority, triple-blind, parallel, multicentre, randomised clinical trial. Scope: Population attending Primary Healthcare Centres in Andalusia (Spain). Sample: 831 immobilised patients at risk of suffering pressure ulcers.ResultsThe follow-up period was 16 weeks. Groups were similar after randomization. In the per protocol analysis, none of the body areas evaluated presented risk differences for pressure ulcers incidence that exceeded the 10% delta value established. Sacrum: Olive Oil 8 (2.55%) vs HOFA 8 (3.08%), ARR 0.53 (-2.2 to 3.26) Right heel: Olive Oil 4 (1.27%) vs HOFA 5 (1.92)%, ARR0.65 (-1.43 to 2.73). Left heel: Olive Oil 3 (0.96%) vs HOFA 3 (1.15%), ARR0.2 (-1.49 to 1.88). Right trochanter: Olive Oil 0 (0%) vs HOFA 4 (1.54%), ARR1.54 (0.04 to 3.03). Left trochanter: Olive Oil 1 (0.32%) vs HOFA 1 (0.38%), ARR0.07 (-0.91 to 1.04). In the intention to treat analysis the lower limit of the established confidence interval was never exceeded.DiscussionThe results obtained confirmed that the use of topical extra-virgin olive oil to prevent PU in the home environment, for immobilised patients at high risk, is not inferior to the use of HOFA. Further studies are needed to investigate the mechanism by which olive oil achieves this outcome.Trial RegistrationClinicaltrials.gov NCT01595347

Effectiveness and safety of olive oil preparation for topical use in pressure ulcer prevention: Multicentre, controlled, randomised, and double‐blinded clinical trial

“…Our final results corroborate the preliminary data obtained in the intermediate analysis . They are also in agreement with the findings of another Spanish research group, who found that an olive oil product and HOFA product were equally effective to prevent PUs in 831 at‐risk patients receiving home care in the province of Malaga …”

“…The present results demonstrate that the therapeutic safety profile of topical treatment with olive oil is equivalent to that of HOFA treatments. No adverse effects were observed in our olive oil group, similar to findings of other studies on the topical application of olive oil on healthy skin and diabetic foot ulcers . Olive oil can therefore be considered a safe product for topical application.…”

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

“…In the between‐groups analysis, conducted at the end of the follow‐up period, per protocol, none of the body areas evaluated presented risk differences for pressure ulcer incidence that exceeded the pre‐established 10% delta value. The intention‐to‐treat analysis showed that the lower limit of the confidence interval established for noninferiority was not exceeded in any of the areas assessed …”

“…By means of a multicenter randomized triple‐blind controlled non‐inferiority trial, we evaluated the noninferiority of virgin extra olive oil vs. HOFA. The results obtained show that none of the body areas evaluated presented risk differences for pressure ulcer incidence that exceeded the pre‐established 10% delta value . However, despite these promising clinical results, to date no information has been published concerning the cost implications of such an intervention.…”

“…This analysis is based on the interventions carried out in a noninferiority triple‐blind parallel multicenter randomized clinical trial, performed in a primary health setting with home care patients. The study protocol, the sample characteristics and the clinical outcomes are reported elsewhere . The study consisted of two different interventions: usual care, with the application of HOFA to the control group, and usual care with the application of an olive oil composition to the target group.…”