OBJECTIVES: The aim of this study was to evaluate the efficacy of Regenera, a medicated absorbent pad containing ozonised solution, in patients with urinary incontinence and pressure injuries (superficial lesions, stage 1 and 2).

METHODS: A randomized, controlled, 1:1 parallel-arms clinical trial was performed enrolling patients with urinary incontinence and superficial pressure injuries (PIs), hospitalized at the Internal Medicine Unit of Ospedale Maggiore in Novara, during the period December 2016-December 2017. The primary endpoint was the recovery rate per treatment group within 10 days from the hospitalization date. A subanalysis for different ranges in the length of hospital stay was also performed.

RESULTS: CONCLUSIONS: This study has showed that innovative devices such as Regenera may play an important role in the management of the fragile elderly population, often affected by PIs in case of hospitalization. Further analysis is needed to assess implications for patient in terms of quality of life and potential economic impact from the NHS perspective.