Efficacy and Safety of Antimicrobial Durations Treatment of Infections Associated With Osteosynthesis Material
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.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
364 participants
Aug 9, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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.
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Interventions
Short duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Long duration of authorized antibiotic therapy according to its data sheet in infections associated with osteosynthesis material
Locations(29)
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NCT05294796