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
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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