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Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices - Trial NCT04787575

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

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NCT04787575
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Trial Details
ClinicalTrials.gov โ€ข NCT04787575
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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

Study Focus

Infection

Oxygen-ozone therapy

Interventional

procedure

Sponsor & Location

Societร  Scientifica Internazionale di Ossigeno Ozono Terapia

Castel Volturno,Fidenza,Milano,Napoli,Pavia,San Benedetto Del Tronto, Italy

Timeline & Enrollment

N/A

Jun 01, 2021

Sep 01, 2022

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, unspecified
Bacterial, viral and other infectious agents
Infection following immunization
Other infectious diseases
Viral infection, unspecified

Data Source

ClinicalTrials.gov

NCT04787575

Non-Device Trial