Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Presence of Wound Infection
研究概览
简要总结
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 - 70 years
- •Gustilo Type I,II,IIIa open fracture (s)
- •Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
- •Subject should be able to follow up at the scheduled times following surgery
- •Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study
排除标准
- •Closed fracture
- •Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
- •Aminoglycoside allergy
- •Presentation greater than 48 hours after injury
- •Pathologic fracture
- •Preexisting infection in bone with an open fracture
- •Patients with multiple trauma involving liver, kidney, or brain
- •Pregnancy (self-reported)
- •Current status as prisoner
研究组 & 干预措施
Antibiotic
Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
干预措施: Tobramycin (Drug)
结局指标
主要结局
Presence of Wound Infection
时间窗: 6 weeks post op
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
次要结局
未报告次要终点
研究者
Seth Yarboro, MD
Assistant Professor Orthopaedic Surgery
University of Virginia