Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 11
- 主要终点
- Occurrence of infection
研究概览
简要总结
The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions:
- What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
- What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation?
Secondary objectives
-
How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
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What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
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What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation?
-
Hospital standard hygienic and antibiotic protocol for infection prevention
-
Subject demographics
-
Time between injury and surgery and between admission and surgery
-
Fracture type (AO Müller classification)
-
Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
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Fracture management and implant type
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Surgical details such as duration of surgery
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Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections?
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Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are 18 years of age or older.
- •Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.
- •Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
- •Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.
排除标准
- •Previous wound infection or osteomyelitis at the same limb (according to subject history).
- •Subjects who plan to undergo conversion surgery at a different hospital.
- •Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
- •Immunological deficiency disease.
- •Tumor related fractures.
- •Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
- •Subject is a prisoner.
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.
结局指标
主要结局
Occurrence of infection
时间窗: From surgery until the date of first documented infection assessed up to 1 year
LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
次要结局
- Change in Quality of life measurement (EQ-5D)(Baseline and up to 5 day postoperative and 3months and 6months and 12 months)