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.
Orthopedic implants for fracture fixation or osteosynthesis material are used for internal fixation of fractures, allowing their stability and consolidation. Infection associated with osteosynthesis material is one of the most feared and challenging complications of trauma surgery and can lead to total loss of function or amputation of the limb, when complete recovery is to be expected without infection. Furthermore, they involve excessive consumption of antimicrobials, with inadequate prescriptions and prolonged durations that favour superinfections by multidrug-resistant microorganisms, in addition to the drug-related toxicities, especially diarrhea due to Clostridium difficile. Most studies and recommendations on the management of orthopedic implant-associated infections have focused on prosthetic joint infections, and while they share similarities with Infections Associated With Osteosynthesis Material Implanted, there are major differences in terms of risk factors, diagnosis, treatment, and prevention. While the extrapolation of knowledge from prosthetic joint infections to the field of Infections Associated With Osteosynthesis Material Implanted has helped orthopedic surgeons and internists/infectologists in their management, there are large gaps and unanswered questions that represent a new challenge for research in this field. One of these challenges, and focusing on the field of infection treatment, is the search for the best surgical procedure according to the age of the implant and fracture healing, to determine the duration of antibiotic treatment and whether it should be maintained until fracture healing, and which is the most appropriate treatment in each of the scenarios. The identification of conditions in which the duration of the antimicrobial treatment can be shortened, and in case of prolonged treatments, which antimicrobial has the best safety profile and less impact on the induction of bacterial resistances is of special interest, due to the frequent appearance of toxicities and the increase of bacterial resistances and superinfections by multidrug-resistant bacteria. If the hypothesis of non-inferiority of short vs. long antibiotic treatments is demonstrated, and the efficacy of antibiotics with less ecological impact in long treatments, the impact on reduction of bacterial resistance, toxicity and health costs will be observed. The project also aims to promote quality and multidisciplinary care, homogenising clinical practice in the management of Infections Associated With Osteosynthesis Material Implanted based on scientific knowledge. Early and personalised patient care with Infections Associated With Osteosynthesis Material Implanted allows for faster recovery, both clinically and functionally, enabling earlier mobility recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
364
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
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain
RECRUITINGHospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital Universitario Parc Taulí
Sabadell, Barcelona, Spain
RECRUITINGHospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Number of participants with clinical cure in the test of cure
A success at the test of cure is the resolution of infection symptoms, the absence of clinical signs and symptoms of infection (persistence of symptoms of infection, relapse of infection after a period without symptoms, or superinfection by a different microorganism) without antibiotic therapy and with C-reactive protein \<10 mg/L (unless another cause justifies a higher C-reactive protein value); If the patient dies, when the death was not related to the infection; and no need for chronic suppressive antibiotic therapy to "control" of the infection.
Time frame: 12 months after completion of antimicrobial treatment
Radiological healing in the test of cure
Radiological healing is defined as the presence of radiological signs of fracture consolidation (plain radiographic or CT) of the infected bone. Non-union or absence of consolidation of a fractured bone is defined when it has not completely healed within 9 months after osteosynthesis surgery or when it has not shown progression towards fracture callus formation in 3 consecutive months on serial radiographs. The REBORNE fracture healing scale will be used for a more accurate assessment of fracture healing on radiographs, or CT if necessary.
Time frame: 12 months after completion of antimicrobial treatment
Definitive soft tissue coverage at test of cure
Number of patients who present definitive soft tissue coverage at test of cure
Time frame: 12 months after completion of antimicrobial treatment
Efficacy of each group of antibiotics
Number of days of antibiotic administration
Time frame: 12 months from the start of antibiotic treatment
Performance of an antibiogram to assess the development of antimicrobial resistance
Standard microbiological techniques will be used to identify microorganisms recovered and to determine antimicrobial susceptibility according to EUCAST recommendation (EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance, Version 2.0, 2017) https://www.eucast.org/fileadmin/src/media/PDFs/EUCAST\_files/Resistance\_mechanisms/EUCAST\_detection\_of\_resistance\_mechanisms\_170711.pdf
Time frame: 8 months and 12 months
Surgical wound culture to assess the development of secondary infections
To evaluate the appearance of secondary infections during antibiotic treatment that standard microbiological techniques will be used to identify microorganisms recovered and to determine antimicrobial susceptibility according to EUCAST recommendation (EUCAST guidelines for detection of resistance mechanisms and specific resistances of clinical and/or epidemiological importance, Version 2.0, 2017) https://www.eucast.org/fileadmin/src/media/PDFs/EUCAST\_files/Resistance\_mechanisms/EUCAST\_detection\_of\_resistance\_mechanisms\_170711.pdf
Time frame: 8 months and 12 months
Recurrence rate
To evaluate the recurrence rate during antibiotic treatment.
Time frame: 8 months and 12 months
Evaluate the need for new surgeries, such as debridement, removal of material, coverage or amputation, through radiological evaluation of fracture union.
To evaluate the need for new surgeries through radiological evaluation
Time frame: Day 28, week 8, week 12, month 6 and month 12.
Evaluation of the functional status, defined as the recovery of the functionality of the limb prior to the fracture, by completing the Quick Disabilities of Arm, Shoulder and Hand questionnaire.
The functional state, normal or reduced, will be evaluated with respect to the situation prior to the fracture. Lower extremity mobility is classified as: walks unassisted; with 1 cane; with 2 canes; with walker; "wander home alone"; not wandering..
Time frame: 6 months and 12 months (visit 6 and 7)
Evaluation the consumption of health resources
Total number and posology of all the antibiotics that have been administered to the patient will be taken into account, in addition to the new surgeries, new microbiological cultures and hospitalizations that have been required.
Time frame: Month 12
Evaluate the number of patients who have required any of the bone or soft tissue reconstruction strategies.
Total number of new surgeries for better bone or soft tissue coverage: number of vacuum therapies (VAC or PICO), total number of grafts or flaps needed by the patient throughout the study.
Time frame: Month 12
Presentation of adverse events (frequency and severity).
Number of adverse events (frequency and severity) that have happened during the study.
Time frame: Through study completion (12 months)
Clostridium difficile infection
Number of cases observed during antibiotic treatment or 30 days after completion.
Time frame: During treatment or 30 days after completion
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Hospital Universitario Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
RECRUITINGHospital San Pedro
Logroño, La Rioja, Spain
RECRUITINGHospital Universitario El Bierzo
Ponferrada, León, Spain
RECRUITINGHospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
RECRUITINGHospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
RECRUITINGHospital Universitario Virgen del Rocío
Seville, Seville, Spain
RECRUITING...and 19 more locations