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临床试验/NCT03148067
NCT03148067已完成不适用

Prospective Study on the Incidence and Risk Factors for the Occurrence of Surgical Site Infection After Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures

University of Sao Paulo0 个研究点目标入组 225 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
225
主要终点
Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures

研究概览

简要总结

Diaphyseal femoral and tibial fractures are in the spotlight within the traumatology-orthopedics scenario. Intramedullary nailing (IMN) remains the method of choice for treating these fractures, both open and closed ones. Occurrences of surgical site infection (SSI) related to this type of osteosynthesis are a challenge for all the professionals involved in patient healthcare. The reported incidence of SSI after IMN ranges from 0.9 to 17.5%. The majority of the data comes from retrospective studies and as part of case series descriptions, with little detail about the criteria used for defining and searching for cases of infection. Regarding the potential risk factors for this complication, previous use of external fixators, occurrence of open fractures and the severity of exposure according to the Gustilo-Anderson classification were indicated in a few retrospective studies as being possibly related to this complication. The objectives of the present observational cohort study are: 1. To determine the incidence of SSI related to IMN for fixation of diaphyseal femoral and tibial fractures in patients treated in a university traumatology and orthopedics reference hospital in São Paulo, Brazil; 2. To evaluate the risk factors related to the occurrence of this type of infection.

详细描述

Diaphyseal femoral and tibial fractures are a important challenge faced by the orthopedic surgeon, due to their high incidence and high social and economic impact. Currently, the observed increases in the rates of injuries secondary to traffic, work and firearms-related accidents, and also those related to sports practice, have led to significant growth of the incidence of these fractures, especially among young and economically active individuals .

Although standardized criteria for indications of conservative treatment exist, surgery is often recommended due to its better functional results and shorter rehabilitation period. Intramedullary nailing (IMN) was introduced by Küntscher in 1939 and remains the method of choice for treating these fractures, both closed and open ones, especially because the surgical technique is considered to be simple, standardized and replicable; does not cause major soft tissue damage and allows early loading. This technique is associated with a higher consolidation rate and lower incidence of complications, among which infections are included.

Surgical site infection (SSI) after internal fracture fixation is considered to be a severe, hard-to-treat complication, and it is important to remember that the presence of the implant itself favors bacterial invasion and alters local immunity, thus hampering the action of granulocytes. In addition, injury to the soft tissues adjacent to the fracture focus also hampers this immunity and favors occurrence of infections.

Although complications are less frequent than in other internal fracture fixation methods, they can occur during the postoperative period, relating to the use of IMN, and these may include SSI. Its occurrence significantly increases recovery time and treatment costs, and it compromises the long-term functional results and rehabilitation.

SSIs, including those related to IMN, are defined internationally in accordance with the criteria established in the United States (USA) by the National Healthcare Safety Network (NHSN), an agency belonging to the Centers for Disease Control and Prevention (CDC). 8 This body is responsible for healthcare-related infection surveillance actions in that country. In Brazil, as in other countries, adaptations made by the local health and epidemiological surveillance authorities are followed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Closed and open diaphyseal femoral and tibial fractures treated through IMN;
  • Age: 16 years or older
  • The patient or a person legally responsible for the patient should sign the free and informed consent statement (FICS) in order to take part in the study.

排除标准

  • No exclusion criteria

结局指标

主要结局

Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures

时间窗: one year after surgery

Patients who present signs of infection in the region of the surgery under evaluation or who describe alterations compatible with SSI, or whose records mention signs or symptoms compatible with the definitions of SSI, are considered to be cases with evolution to infection. Patients included in the study who, during routine or emergency care present a condition (according to the researchers' evaluation) suggestive of a SSI associated with intramedullary nailing are considered to be cases of infection

次要结局

  • Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing(one year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscila Rosalba Domingos de Oliveira

MD, MSc

University of Sao Paulo

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