Treatment of Fracture Related Infection in Latin America. International Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Usefulness of the FRI diagnosing criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Incomplete medical records
结局指标
主要结局
Usefulness of the FRI diagnosing criteria
时间窗: at least 6 months after infection treatment
To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.
次要结局
- Microbiological profile(just after infection treatment)
- Surgical treatment(at least 12 months after infection treatment)
- Strategies for the management of soft tissue defects(at least 6 months after infection treatment)
- Variables associated with outcomes(at least 12 months after infection treatment)
- Quality of life - EQ-5D-3L(at least 12 months after infection treatment)
研究者
Matheus Lemos Azi
Principal Investigator
Manoel Victorino Hospital