Oxygen-ozone therapy combined with antibiotics for treating infections from orthopedic implants

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

This study is testing if adding oxygen-ozone therapy to antibiotics can help people with infections from orthopedic implants feel better compared to just using antibiotics alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Società Scientifica Internazionale di Ossigeno Ozono Terapia (Academic / other)
• Drugs / interventions: radiation
• Locations: 6 sites (Castel Volturno, Caserta and 5 other locations)
• Trial ID: NCT04787575 on ClinicalTrials.gov

What this trial studies

This open-label, multicentre, randomized study evaluates the effectiveness of oxygen-ozone therapy alongside oral antibiotics compared to antibiotics alone in treating infections related to orthopedic device implants. Patients will be screened and randomized into two groups: one receiving both therapies and the other receiving only antibiotics. Follow-up visits will occur at specified intervals to assess the resolution of infection symptoms. The study aims to determine if the addition of oxygen-ozone therapy improves patient outcomes in this context.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone recent surgery for orthopedic device implantation and exhibit signs of infection at the surgical site.

Not a fit: Patients without post-operative infections or those who do not have an orthopedic device implant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the healing process and reduce infection rates in patients with orthopedic implants.

How similar studies have performed: While the combination of oxygen-ozone therapy and antibiotics is a novel approach, similar studies have shown promise in using oxygen therapies for wound healing.

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 perform the wound self-care at home or care by his/her primary caregiver;
10. Willing to refrain from all non-permitted concomitant medication from the screening visit through to the entire study duration.
11. Female subjects of childbearing potential must have a negative urinary pregnancy test at Screening and must practice a reliable method of contraception throughout the study;
12. Patient able to read and understand the study procedures, the requirements for follow-up visits, willing to provide information at the scheduled evaluations and willing, able and ensuring to comply with the study requirements for the whole study period.

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 tissue disease;
8. Patients with active malignant disease;
9. Patients with other clinically significant diseases, or other major diseases deemed clinically significant by the Investigator or which in the opinion of the Investigator would 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 systemic corticosteroids 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 or immunosuppressive therapies;
14. Patients with contraindications to antibiotic therapy;
15. Pregnant, breastfeeding women and female child-bearing potential who are not using a highly effective method of birth control and not willing to use it during the participation to the study;
16. Participation in any clinical research study evaluating another investigational drug or device within 30 days prior to consenting to study entry;
17. Patient unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.

Where this trial is running

Castel Volturno, Caserta and 5 other locations

• Pineta Grande Hospital — Castel Volturno, Caserta, Italy (Recruiting)
• Ospedali Riuniti Torrette — Ancona, Italy (Not_yet_recruiting)
• Università Federico II — Napoli, Italy (Not_yet_recruiting)
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo — Palermo, Italy (Not_yet_recruiting)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
• Casa Di Cura Citta' Di Roma — Roma, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Antonio Guastafierro — Pineta Grande Hospital
• Study coordinator: Marianno Franzini

Conditions Infection; Orthopaedic device