Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material

NCT05294796 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2024-08-30

No results posted yet for this study

Summary

Infections associated with osteosynthesis material are among the most feared and challenging complications of trauma surgery and can lead to total function loss or limb amputation when complete recovery is to be expected without infection.

This is a clinical trial with the purpose of evaluate the optimal duration of antibiotic therapy in Infections Associated With Osteosynthesis Material Implanted when implant is retained.

Conditions

Interventions

COMBINATION_PRODUCT

Short course of antibiotherapy

Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material

COMBINATION_PRODUCT

Long course of antibiotherapy

Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • María Dolores del Toro López · Hospital Universitario Virgen Macarena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2024-10-31
Completion
2026-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05294796 on ClinicalTrials.gov