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Treatment of Fracture Related Infection in Latin America.

Treatment of Fracture Related Infection in Latin America. International Multicenter Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05467644
Enrollment
300
Registered
2022-07-20
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Fracture, Osteomyelitis, Soft Tissue Injuries

Keywords

Fracture, Osteomyelitis, Soft Tissue Injuries, Bone Loss

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).

Interventions

PROCEDURETreatment of Fracture Related Infection

Observational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment

Sponsors

AO Trauma Latin America
CollaboratorUNKNOWN
Centro Médico Nacional de Occidente IMSS
CollaboratorUNKNOWN
University of Campinas, Brazil
CollaboratorOTHER
Hospital Municipal Miguel Couto
CollaboratorOTHER
Hospital Italiano de Buenos Aires
CollaboratorOTHER
Hospital Pablo Tobón Uribe
CollaboratorOTHER
Manoel Victorino Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Usefulness of the FRI diagnosing criteriaat least 6 months after infection treatmentTo analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.

Secondary

MeasureTime frameDescription
Surgical treatmentat least 12 months after infection treatmentDescribe the strategies of surgical treatment in patients with infections related to fractures
Microbiological profilejust after infection treatmentDescribe the microbiological profile of fracture-related infections in Latin American centers.
Variables associated with outcomesat least 12 months after infection treatmentTo explore variables associated with the outcome of fracture-related infection control
Strategies for the management of soft tissue defectsat least 6 months after infection treatmentDescribe the strategies for the management of soft tissue defects associated with infections related to fractures.
Quality of life - EQ-5D-3Lat least 12 months after infection treatmentDescribe the results in terms of the quality of life of patients with infections related to fractures

Countries

Brazil

Contacts

Primary ContactMatheus Azi, PhD
matheus.azi@saude.ba.gov.br+557132541250
Backup ContactNilma Caldas
residenciamedicahmv@gmail.com+557132541250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026