NCT04787575

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Società Scientifica Internazionale di Ossigeno Ozono Terapia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infection

Interventions

Type	Name	Description
PROCEDURE	Oxygen-ozone therapy	Oxygen-ozone therapy (group a) will be performed by: i) Self-haemoinfusion of 200 cc. with concentrations of 40-50 μg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 μg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas

Timeline

• Start date: 2024-01-24
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2021-03-08
• Last updated: 2024-04-17

Locations

6 sites across 1 country: Italy