ACTRN12621001655831尚未招募3 期
The effect of Topical Antibiotics in Ankle Fracture Surgery (TAAFS) on the rate of surgical site infections: a pilot study
Dr William O'Callaghan0 个研究点目标入组 332 人开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 332
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients aged 18 and older
- •Injury meeting the following criteria:
- •a.Open or Closed Ankle Fracture
- •b.Definitively treated with plate and screw fixation
排除标准
- •Patients with fractures that have evidence of active infection (fracture related infection) or have evidence of systemic infection or sepsis (chest infection, urinary traction infection or similar) or other unrelated orthopaedic infection such as a prosthetic joint or chronic musculoskeletal infection for which they are currently on treatment for
- •Patients with adjacent fractures to the same limb – tibia pilon, tibial shaft, talus, or mid foot fractures requiring operative intervention
- •Patients with bilateral ankle injuries due to the risk of systemic antibiotic toxicity from dual dosage and confounding of placebo results
- •Patients with a subsequent injury who have previously been enrolled in the study for the contralateral limb
- •Patients with periprosthetic ankle fractures with existing orthopaedic implants
- •Patients with open G3 Gustilo-Anderson injuries who will not undergo primary coverage or closure at the time of fixation and will have such treatment scheduled for a subsequent procedure date
- •Patients who have already had definitive fixation before enrollment in the trial
- •Patients with an allergy or history of adverse drug reaction to vancomycin
- •Patient with an allergy or history of adverse drug reaction to gentamicin
- •Patients who are currently pregnant
- •Patients who are do not speak English
- •Patients who are incarcerated
- •Patients who are determined by the local investigators to have severe difficulties in maintaining follow-up for the following reasons:
- •oDiagnosis of a severe psychiatric disorder that is not adequately controlled
- •oPatients without capacity or lack family support to participate in follow-up
- •oPatients living remote from the study site who are unable to be followed up at any of the study sites
- •oPatients who are homeless without adequate contact information to facilitate follow-up
研究者
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