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

NCT04787575 | Recruiting

• 1 other identifier: sOO3T1 Study
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 6

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.

Conditions

Infection

Keywords

Infection; Orthopaedic device

Outcome Measures

Primary Outcomes (1)

• Clinical success at Day 14

  Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score ≤ 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour. The following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.

  2 week

Secondary Outcomes (9)

• Proportion of patients with clinical success at Day 7, Day 28, and Day 42

  Day 7, Day 28, and Day 42

• Time to resolution of all signs and symptoms of infection

  7 weeks

• Eradication of the pathogen isolated at the screening visit

  7 weeks

• Changes from baseline to any post-baseline time-point of the size of the target lesion

  7 weeks

• Global assessment of the target lesion at Day 14 and Day 42

  7 weeks

Other Outcomes (21)

• Number of subjects experiencing treatment-emergent adverse events and serious TEAEs

  7 weeks

• Number of subjects experiencing local TEAEs in the site of application of the IP

  7 weeks

• Changes from baseline to any post-baseline time point in blood pressure

  7 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Oxygen-ozone therapy plus antibiotic therapy

Procedure: Oxygen-ozone therapy

Arm B

OTHER

Antibiotic therapy

Procedure: Oxygen-ozone therapy

Interventions

Oxygen-ozone therapy PROCEDURE

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Male or female aged ≥ 18 years;
• Patient having undergone surgery for implant of an orthopaedic device in the previous 8 weeks;
• Presence of at least one (but no more than 3) post-operative wounds in the site of surgery (ulcers, eschars, sores);
• 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);
• Wound area of the target lesion ≤ 100 cm2;
• 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;
• 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);
• Patient able to perform the wound self-care at home or care by his/her primary caregiver;
• Willing to refrain from all non-permitted concomitant medication from the screening visit through to the entire study duration.
• 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;
• 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.

You may not qualify if:

• Wounds without signs of localized infection;
• Presence of more than four wounds;
• Presence of one or more wounds with area \> 100 cm2;
• Presence of undermining wounds;
• Patients with favism, i.e. deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme;
• Patients with uncontrolled hyperthyroidism;
• Patients with history of connective tissue disease, e.g., mixed connective tissue disease;
• Patients with active malignant disease;
• 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;
• Patients candidate to any surgery during the overall study duration;
• Treatment with topical corticosteroids in the previous 4 weeks and/or with systemic corticosteroids in the previous 7 days;
• Treatment with any hydrating and/or moisturizing cream in the previous 24 hours.
• Patients on treatment with chemotherapeutic agents, radiation therapy or immunosuppressive therapies;
• Patients with contraindications to antibiotic therapy;
• 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;

Sponsors & Collaborators

• Società Scientifica Internazionale di Ossigeno Ozono Terapia: lead

Study Sites (6)

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

Related Publications (1)

• Cascini F, Franzini M, Andreoli A, Manzotti A, Cadeddu C, Quaranta G, Gentili A, Ricciardi W. Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial. BMJ Open. 2024 Jan 4;14(1):e076739. doi: 10.1136/bmjopen-2023-076739.

  PMID: 38176866 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Antonio Guastafierro

  PINETA GRANDE HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianno Franzini

CONTACT

035 19910105; info@ossigenoozono.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, multicentre, randomized, parallel group study

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 8, 2021
• Study Start: January 24, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)