Status:
RECRUITING
Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Infections
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief 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 recove...
Detailed Description
Orthopedic implants for fracture fixation or osteosynthesis material are used for internal fixation of fractures, allowing their stability and consolidation. Infection associated with osteosynthesis ...
Eligibility Criteria
Inclusion
- Age greater than or equal to 14 years.
- Stable fracture, even if unconsolidated.
- Controlled infection (absence of signs or symptoms of sepsis).
- Early or delayed infection.
- Availability of antibiotics active against the isolated microorganism.
- Absence of bone exposure. Patients who initially had bone exposure but during the debridement surgery bone coverage was performed by any method (skin approximation, grafting, vacuum therapy) can be included in the criteria.
- Signed written informed consent.
- If there is a possibility of pregnancy (in women of childbearing potential) or paternity, agree to use a highly effective method of birth control recommended by the Clinical Trial Facilitation Group (CTFG) during the treatment phase of the trial
Exclusion
- Late infections
- Infections of osteosynthesis material in non-long bones.
- Infections of revision osteosynthesis material or occurring after previous surgeries.
- Patients who are not expected to be followed up for at least 1 year after completion of antibiotic treatment.
- Pregnant or lactating women.
- Patients in whom there may be drug interactions or contraindications described in the technical data sheets of the investigational drugs used in this trial.
- Infections due to mycobacteria, fungi and parasites (since they are infections that are treated with drugs and for different durations).
- Patients in whom all the material is replaced during the debridement at the same surgical time (since these patients require antibiotic treatment for less than 8 weeks in all cases).
- Infections of external fixators.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT05294796
Start Date
August 9 2022
End Date
April 1 2026
Last Update
August 30 2024
Active Locations (29)
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1
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain, 07120
2
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital Universitario Parc Taulí
Sabadell, Barcelona, Spain, 08208
4
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008