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

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 ofsurgery (ulcers, eschars, sores);
5. Presence of at least one symptom (pain, burning, redness and malodour) and at leastone sign (erythema, local warmth, swelling, purulent secretion) of infection of atleast 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 thetarget 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 notoverlap with the target one (i.e. the largest one);
9. Patient able to perform the wound self-care at home or care by his/her primarycaregiver;
10. Willing to refrain from all non-permitted concomitant medication from the screeningvisit through to the entire study duration.
11. Female subjects of childbearing potential must have a negative urinary pregnancy testat Screening and must practice a reliable method of contraception throughout thestudy;
12. Patient able to read and understand the study procedures, the requirements forfollow-up visits, willing to provide information at the scheduled evaluations andwilling, able and ensuring to comply with the study requirements for the whole studyperiod.

Exclusion Criteria:

1. Wounds without signs of localized infection;
2. Presence of more than four wounds;
3. Presence of one or more wounds with area > 100 cm2;
4. Presence of undermining wounds;
5. Patients with favism, i.e. deficiency of the glucose-6-phosphate dehydrogenase (G6PD)enzyme;
6. Patients with uncontrolled hyperthyroidism;
7. Patients with history of connective tissue disease, e.g., mixed connective tissuedisease;
8. Patients with active malignant disease;
9. Patients with other clinically significant diseases, or other major diseases deemedclinically significant by the Investigator or which in the opinion of the Investigatorwould interfere with the study procedures or study outcome;
10. Patients candidate to any surgery during the overall study duration;
11. Treatment with topical corticosteroids in the previous 4 weeks and/or with systemiccorticosteroids in the previous 7 days;
12. Treatment with any hydrating and/or moisturizing cream in the previous 24 hours.
13. Patients on treatment with chemotherapeutic agents, radiation therapy orimmunosuppressive therapies;
14. Patients with contraindications to antibiotic therapy;
15. Pregnant, breastfeeding women and female child-bearing potential who are not using ahighly effective method of birth control and not willing to use it during theparticipation to the study;
16. Participation in any clinical research study evaluating another investigational drugor device within 30 days prior to consenting to study entry;
17. Patient unable to understand informed consent or having a high probability ofnon-compliance with the study procedures and or non-completion of the study accordingto investigator's judgement.