Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices

Infection Clinical Trial

Official title: Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices

Status Recruiting

Clinical Trial Summary

This is an open-label, multicentre, randomized, parallel group study to evaluate the efficacy of treatment with oxygen-ozone therapy plus oral antibiotic therapy, in comparison with oral antibiotic therapy alone, in the proportion of patients with resolution/improvement of signs and symptoms of infection of the wound (e.g. ulcer, eschar, sore) in the target lesion after 14 days of treatment, in patients with infections secondary to implant of orthopaedic devices.

Clinical Trial Description

This will be an open-label, multicentre, randomized, parallel group study. The study plan will include a screening visit (Visit 1, Day -7/-3) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated.

At the end of the 3-7 days of run-in (Visit 2, Baseline visit, Day 0), patient still eligible will be randomised to one of the two following treatment groups:

1. Oxygen-ozone therapy SIOOT plus antibiotic therapy

2. Antibiotic therapy

Patients in both groups will receive oral antibiotic therapy, which will be prescribed at discretion of the Investigator, based on the results of the colture of the swab collected in the target lesion at the screening visit (and later, if needed) and the associated antibiogram.

Follow-up visits will be performed after 7 days (Visit 3, Day 7), 14 days (Visit 4, Day 14), 28 days (Visit 5, Day 28) and 42 days (Visit 6, End of study, Day 42) from the start of treatment.

A visit window of ± 2 days for the date of Visits 3-5 and of ± 3 days for the date of Visits 6 will be allowed.

Patients prematurely discontinued from the study will perform an 'Early termination visit', in which procedures schedule for Visit 6 (End of study, Day 42) will be performed. In case of premature study discontinuation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (eCRF).

Visit 6, or the 'Early termination Visit' will represent the conclusion of patient's participation in the investigation. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

• NCT number: NCT04787575
• Study type: Interventional
• Source: Società Scientifica Internazionale di Ossigeno Ozono Terapia
• Contact: Marianno Franzini
• Phone: 035 19910105
• Email: info@ossigenoozono.it
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Completion date: January 2026