A Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures
概览
- 阶段
- 不适用
- 干预措施
- local gentamicin injection
- 疾病 / 适应症
- Open Tibia Fracture
- 发起方
- University of California, San Francisco
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Enrollment
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.
详细描述
This pilot study is being conducted in Dar es Salaam, Tanzania to assess the feasibility of a masked, placebo-controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. The study will enroll patients within 1 week of injury. The active or placebo agent will be administered during the initial surgical debridement based on a web-based randomization tool. Patients will be followed for 1 year after surgery to assess for the occurrence of fracture-related infection (FRI), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. Additional clinical and economic endpoints will also be measured. Depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent FRI. If proven effective, local gentamicin would impact the clinical care of open fracture patients both in Tanzania and likely in high-income settings as well. These data will also deepen the understanding of the clinical and economic impact of FRI in open fracture populations.
研究者
入排标准
入选标准
- •Male or female patients age 18 or older
- •Diagnosis of an acute open tibial shaft fracture meeting the following criteria:
- •AO/OTA Type 42
- •Primarily closable wound
- •Type I, II, or IIIA Gustilo- Anderson (GA) Classification
排除标准
- •Time from injury to presentation \> 48 hours
- •Time from injury to surgery \>7 days
- •History of Aminoglycoside allergy
- •GA IIIB or IIIC open fractures
- •Bilateral open tibial fractures
- •Severe brain (GCS\<12) or spinal cord injury
- •Severe vascular injury
- •Sustained severe burns (\>10% total body surface area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
- •Pathologic fracture
- •History of active limb infection, ipsilaterally
研究组 & 干预措施
gentamicin injection at fracture site
Subjects with an open tibia fracture who receive gentamicin in saline solution administered after closure at the time of initial debridement.
干预措施: local gentamicin injection
placebo saline injection at fracture site
Subjects with an open tibia fracture who receive placebo saline solution administered after closure at the time of initial debridement.
干预措施: placebo saline injection
结局指标
主要结局
Rate of Enrollment
时间窗: Baseline
The number of participants enrolled in the clinical trial per month will be measured to assess feasibility of the definitive clinical trial.
Rate of Retention
时间窗: 1 year
The percentage of patients completing 1 year follow up relative to the total number of participants
Occurrence of Fracture-related Infection (FRI)
时间窗: 1 year
The primary outcome for the definitive trial is occurrence of fracture-related infection (FRI), a binary variable. Any of the four following diagnostic criteria are confirmatory for FRI: 1. fistula, sinus or wound breakdown 2. purulent drainage from the wound or presence of pus during surgery 3. phenotypically indistinguishable pathogens identified by culture from at least two separate deep tissue/implant specimens 4. presence of microorganisms in deep tissue taken during an operative intervention, as seen on histopathological examination. All primary events will be reviewed by a masked adjudication committee comprised of 3 non-treating fellowship-trained orthopaedic trauma surgeons.
次要结局
- Modified Radiographic Union Scale for Tibial Fractures (mRUST) Score(1 year)
- Occurrence of Fracture-related Reoperation(1 year)
- Euro-Qol 5 Dimensions (EQ-5D)(1 year)
- Occurrence of Nonunion(1 year)
- Function Index for Trauma (FIX-IT) Score(1 year)