Treatment of Fracture Related Infection in Latin America.

Sponsor

Manoel Victorino Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05467644

Collaborator

AO Trauma Latin America (Other), Centro Médico Nacional de Occidente IMSS (Other), University of Campinas, Brazil (Other), Hospital Municipal Miguel Couto (Other), Hospital Italiano de Buenos Aires (Other), Hospital Pablo Tobón Uribe (Other)

300

Enrollment

Location

35.9

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture Osteomyelitis Soft Tissue Injuries Bone Loss	Procedure: Treatment of Fracture Related Infection

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Usefulness of the FRI diagnosing criteria [at least 6 months after infection treatment]
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.

Secondary Outcome Measures

Surgical treatment [at least 12 months after infection treatment]
Describe the strategies of surgical treatment in patients with infections related to fractures
Microbiological profile [just after infection treatment]
Describe the microbiological profile of fracture-related infections in Latin American centers.
Variables associated with outcomes [at least 12 months after infection treatment]
To explore variables associated with the outcome of fracture-related infection control
Strategies for the management of soft tissue defects [at least 6 months after infection treatment]
Describe the strategies for the management of soft tissue defects associated with infections related to fractures.
Quality of life - EQ-5D-3L [at least 12 months after infection treatment]
Describe the results in terms of the quality of life of patients with infections related to fractures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

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.