Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent; 2. Male or female aged ≥ 18 years; 3. Patient having undergone surgery for implant of an orthopaedic device in the previous 8 weeks; 4. Presence of at least one (but no more than 3) post-operative wounds in the site of surgery (ulcers, eschars, sores); 5. Presence of at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling, purulent secretion) of infection of at least moderate intensity (score ≥ 2) in the target lesion at the screening visit (Visit 1), to be confirmed again at the baseline visit (Visit 2); 6. Wound area of the target lesion ≤ 100 cm2; 7. Patient with presence at least one pathogen identified in the swab collection in the target lesion, which is amenable to be eradicated with oral antibiotic therapy; 8. In case of multiple wounds (however not more than three), non-target lesions must not overlap with the target one (i.e. the largest one); 9. Patient able to