The use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomized, parallel trial

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Abstract Introduction.Surgical site infections still remain a major public health challenge and have become an increasing universal risk, especially for implantation of orthopaedic devices. Ozone therapy has been extensively used and studied for decades across various potential medical applications and has provided consistent effects with minimal side effects. This study aims to determine the superiority of oxygen-ozone therapy in combination with oral antibiotic therapy in patients with wound infections after an orthopaedic device’s implantation, when compared to antibiotic therapy alone.Methods and analysis.This is an open-label, multicentre, randomized, parallel-group study to assess efficacy and safety of oxygen-ozone therapy in combination with oral antibiotic therapy to treat infections following an orthopaedic implant. Patients (n=186) will be recruited from 12 Italian hospitals and studied for 7 weeks. All will be randomized and placed into either the (1) intervention: oxygen-ozone therapy two to three times a week for 6 weeks (for a maximum of 15 sessions) simultaneously with an appropriate oral antibiotic therapy prescribed at baseline; or (2) control: oral antibiotic therapy prescribed at baseline. Primary outcome is the efficacy and superiority of the treatment (ozone and oral antibiotic therapies); secondary outcomes include the resolution of signs/symptoms, modifications in lesion size and treatment’s safety and tolerability.Ethics and dissemination.This study will be reviewed and approved by the Independent Ethics Committee (IEC) of all participating centres prior to starting. Findings will be disseminated via online and print media, events, and peer-reviewed journals.Trial Registration Number:NCT04787575

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