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NCT04787575Not yet recruiting

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
Società Scientifica Internazionale di Ossigeno Ozono TerapiaClinicalTrials.govprocedure
Verified
Study focus
Disease/Condition
Infection
Drug/Device/Intervention
Oxygen-ozone therapy
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Società Scientifica Internazionale di Ossigeno Ozono Terapia
Location
Castel Volturno,Fidenza,Milano,Napoli,Pavia,San Benedetto Del Tronto, Italy
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2021
End date
Sep 01, 2022
Enrollment
186 participants
Primary outcome

Clinical success at Day 14

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.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsInfection following immunizationOther infectious diseasesViral infection, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04787575
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04787575 through Pure Global AI's free database. This phase not specified trial is sponsored by Società Scientifica Internazionale di Ossigeno Ozono Terapia and is currently Not yet recruiting. The study focuses on Infection. Target enrollment is 186 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.