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Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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.
Official title: Efficacy and Safety of Different Antimicrobial Durations for the Treatment of Infections Associated With Osteosynthesis Material Implanted After Long Bone Fractures (DURATIOM). Phase 3 Pragmatic Multicenter Open Labelled Randomized Trial.
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2022-08-09
Completion Date
2026-04
Last Updated
2024-08-30
Healthy Volunteers
No
Conditions
Interventions
Short course of antibiotherapy
Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Long course of antibiotherapy
Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Locations (29)
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Universitario El Bierzo
Ponferrada, León, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Virgen del Rocío
Seville, Seville, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitario Puerto Real
Cadiz, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Costa del Sol
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain