An observational study in Fracture, Osteomyelitis and Soft Tissue Injuries, sponsored by Manoel Victorino Hospital. Status unknown at 1 site in Brazil. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Manoel Victorino Hospital · Observational
Postoperative bone infection is a severe complication in the treatment of fractures and is more frequent than in elective joint replacement surgeries. Surgical treatment is based on meticulous debridement of bone and soft tissue, dead space management, soft tissue reconstruction when necessary, and restoration of bony stability in the non-union fracture. In addition, local antibiotic therapy is recommended in certain circumstances. This study aims to evaluate the results of surgical treatment of fracture-related infection in Latin America.
Research question: What are the characteristics and the diagnostic and therapeutic approach of patients with fracture-related infections (FRI) managed in various centers in Latin America?
Objectives:
General objective Describe the treatment of FRI in different institutions in Latin America, emphasizing the diagnostic process and the surgical and medical approach to this type of patient.
Specific objectives:
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing FRI.
Describe surgical treatment strategies in patients with FRI. Describe the microbiological profile of FRI in Latin American centers To explore variables associated with outcomes. Describe strategies for managing soft tissue defects associated with FRI. Describe the results regarding patients' quality of life with FRI.
Methodology:
Type of study: Observational retrospective cohort study
Outcomes to evaluate:
Infectious relapse: Presence of confirmatory or suggestive clinical signs of infection related to fractures, according to the FRI consensus criteria, within the first year of follow-up after the main surgery for the treatment of infection, and that motivates an intervention additional (Surgery or additional antibiotics) Consolidation: defined as clinical and radiological consolidation. Clinical consolidation - the absence of pain on local palpation and with load or walking. Radiological consolidation - Presence of bone trabeculae in the fracture line in the four cortices of the two standard radiological projections.
Complications: Defined as any adverse event that requires surgery for treatment. It can be "immediate" (those requiring an additional surgical procedure within up to 30 days of treatment of the infection. Examples: hematoma, debridement, change of fixators, change of implant, even if partial) or "late" ( those that required surgical procedure after 30 days of definitive treatment (for example debridement, implant failure, bone grafting).
Proposed statistical analysis: Descriptive statistics tools will be used for qualitative variables, absolute and relative frequencies, quantitative variables, measures of central tendency such as mean or median, and measures of dispersion such as standard deviation or interquartile range, according to the distribution of the variables. Univariate analyses will be performed to explore the relationship of different variables with the risk of infectious relapse, treatment failure, and amputation. All statistical analyzes will be executed in SPSS Statistics® v20 (IBM, Chicago, IL).
113 studies on the registry are indexed under Osteomyelitis; 33 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 50 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →This is the only study on the registry with Manoel Victorino Hospital as lead sponsor.
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Patients diagnosed with Fracture-related Infection
Exclusion Criteria:
Observational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment
Usefulness of the FRI diagnosing criteria
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.
Time frame: at least 6 months after infection treatment
Surgical treatment
Describe the strategies of surgical treatment in patients with infections related to fractures
Time frame: at least 12 months after infection treatment
Microbiological profile
Describe the microbiological profile of fracture-related infections in Latin American centers.
Time frame: just after infection treatment
Variables associated with outcomes
To explore variables associated with the outcome of fracture-related infection control
Time frame: at least 12 months after infection treatment
Strategies for the management of soft tissue defects
Describe the strategies for the management of soft tissue defects associated with infections related to fractures.
Time frame: at least 6 months after infection treatment
Quality of life - EQ-5D-3L
Describe the results in terms of the quality of life of patients with infections related to fractures
Time frame: at least 12 months after infection treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Six countries are involved in the study, and they have different regulations regarding handling patient data. Therefore, researchers will assess data sharing during the data analysis phase of the study.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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