Clinical trial NCT05467644: Treatment of Fracture Related Infection in Latin America.
Official title: Treatment of Fracture Related Infection in Latin America. International Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture
Osteomyelitis
Soft Tissue Injuries
Bone Loss
Keywords: Fracture
Osteomyelitis
Soft Tissue Injuries
Bone Loss
Lead sponsor: Manoel Victorino Hospital
Sponsor class: OTHER_GOV
Collaborators: name: AO Trauma Latin America
name: Centro Médico Nacional de Occidente IMSS
name: University of Campinas, Brazil
name: Hospital Municipal Miguel Couto
name: Hospital Italiano de Buenos Aires
name: Hospital Pablo Tobón Uribe
First posted: 2022-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Fracture-related Infection

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years or older)
* Infection after surgical fracture treatment occurred 90 days after the initial surgery.
* Definitive treatment in one of the centers involved
* Hospital admission from January 1, 2018, to December 31, 2020
* Minimum outpatient follow-up period of one year after the main surgery to treat the infection, assess the quality of life, and control of the infection.

Exclusion Criteria:

* Incomplete medical records

Primary outcomes:
measure: Usefulness of the FRI diagnosing criteria
timeFrame: at least 6 months after infection treatment
Secondary outcomes:
measure: Surgical treatment
timeFrame: at least 12 months after infection treatment
measure: Microbiological profile
timeFrame: just after infection treatment
measure: Variables associated with outcomes
timeFrame: at least 12 months after infection treatment
measure: Strategies for the management of soft tissue defects
timeFrame: at least 6 months after infection treatment
measure: Quality of life - EQ-5D-3L
timeFrame: at least 12 months after infection treatment
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Manoel Victorino Hospital
state: Bahia
Study officials:
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