跳至主要内容
临床试验/NCT05363462
NCT05363462已完成不适用

Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection

Universidad Autonoma de Nuevo Leon1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Rate of surgical infection site

研究概览

简要总结

Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures.

Surgical site infections can be divided according to the Center of Disease Control (CDC) in superficial surgical site infections whose are defined as any infection that happens within the next 30 days after the procedure, they involve only the skin and subcutaneous tissue of the incision, and the patient presents at least one of the following: purulent drainage of the superficial incision, microorganisms isolation from an aseptically obtained culture of body fluid or tissue or the pain existence, tenderness or local inflammation at the superficial incision site despite negative cultures. Also, a diagnosis made by the surgeon or attending medic.

详细描述

Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures. Despite the improvement in the ankle fracture management, it has been estimated that the ankle fracture incidence has been increasing and one of the motives is an increase of ageing population. It has been estimated that ankle fractures have an incidence between 71 to 187 cases per 100,000 inhabitants a year.

Most of the ankle fractures are due to fallings or traffic accidents, it has been reported that up to 71% from ankle fracture causes are due to mechanisms of low energy, especially among the elderly and those with comorbidities these injuries are commonly caused by the inversion of the ankle, where the force and weight of the body falls in the fibula, which in young individuals usually results in only an ankle sprain, being the conservative management the most effective treatment. Nevertheless, in aging patients, these same mechanisms can provoke a fracture.

Ankle fractures represent a challenge for the orthopedic surgeon because in this very joint, despite being relatively stable, rests the entire bodyweight and a correct approach is required for the functionality to not being affected.

Ankle fractures are classified according to AO/OTA and Danis-Weber classifications. Single malleolus fractures are the most frequent (43.7 - 10%) and inside the Orthopedic Trauma Association (OTA) classification, type B are more common with a 65.8%, which tend to be displaced fractures. In patients with unstable or displaced fractures, or where a severe dislocation exists, surgical intervention is advised.

These injuries require a surgical treatment, which brings another issue: surgical site infections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The patients involved in the protocol will be blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients older than 18 years
  • Patients with a closed fracture independently of mechanism and classification
  • Patients who require an open reduction with internal fixation surgery
  • Patients who decide to participate in the study

排除标准

  • Patients with exposed fractures
  • Presence of any form of immune deficiency
  • Vancomycin hyper sensibility
  • Surgery in the affected ankle within the last six months
  • Steroid usage
  • Antibiotic usage one week prior entry

研究组 & 干预措施

Ankle fracture surgical treated plus 1 g of topical vancomycin

Experimental

A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system. Plus application of 1 g of vancomycin in powder in the surgical site

干预措施: Vancomycin 1000 MG (Drug)

Ankle fracture surgical treated

Active Comparator

A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system

干预措施: Vancomycin 1000 MG (Drug)

结局指标

主要结局

Rate of surgical infection site

时间窗: 90 days

Defined as the number of patients with surgical infection site from the total of evaluated patients included in each group.

次要结局

未报告次要终点

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos A Acosta-Olivo

Professor

Universidad Autonoma de Nuevo Leon

研究点 (1)

Loading locations...

相似试验