Treatment of Fracture Related Infection in Latin America.

July 19, 2022 updated by: Matheus Lemos Azi, Manoel Victorino Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Fracture-related Infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usefulness of the FRI diagnosing criteria
Time Frame: at least 6 months after infection treatment
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.
at least 6 months after infection treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manoel Victorino Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRI LATIN AMERICA - AOLAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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