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临床试验/NCT04964947
NCT04964947已完成3 期

Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

Massachusetts General Hospital6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
600
试验地点
6
主要终点
Rate of infection

研究概览

简要总结

The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Open fracture to arm, leg, or both
  • Over the age of 18

排除标准

  • Under the age of 18
  • Allergy to tobramycin or any other antibiotic in the aminoglycoside family
  • Previously treated with a resorbable antibiotic carrier
  • Pregnancy

研究组 & 干预措施

Tobramycin Treatment Group

Experimental

Participants in this group receive a local aqueous tobramycin injection (2mg/mL) plus standard of care treatment.

干预措施: Tobramycin Injection (Drug)

Standard of Care Treatment Group

No Intervention

Participants in this group receive standard of care treatment.

结局指标

主要结局

Rate of infection

时间窗: 1 year

Rate of infection one year after open fracture fixation surgery.

次要结局

  • Difference in antibiotic resistance between treatment and standard of care group.(12 months)
  • Tobramycin effects on non-union(12 months after surgery)
  • Difference in bacterial specification between treatment and standard of care group.(12 months)

研究者

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

Arun Aneja, MD, PhD

Orthopaedic Trauma Surgeon

Massachusetts General Hospital

研究点 (6)

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