A protocol for a randomized trial measuring flowmetry in risk areas for pressure ulcer: Hyperoxygenated fatty acids vs olive oil.

Background: Pressure ulcers are a common adverse event in healthcare. To date, no flowmetry studies have been conducted to compare hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO) in alleviating this condition.

Aims: To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients.

Design: Two-phase experimental study.

Methods: Phase 1 will be conducted with healthy subjects, using a randomised, open study design, evaluating an intrasubject control group. Phase 2 will focus on hospitalised subjects, with a randomised, open study group vs. a control group.

Discussion: This Project is undertaken to identify the mechanisms that intervene in the genesis of pressure ulcers and to determine whether there are differences in outcomes between the application of HFA vs. EVOO as a preventive measure The results of this study are of economic importance (due to the price difference between the products used) and will also impact on usual clinical practice for patients with impaired mobility and liable to suffer from pressure ulcers, by considering an alternative to established preventive measures.