Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (Vancomycin Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,036
- 试验地点
- 2
- 主要终点
- Number of Clinically Significant Deep Surgical Site Infection (SSI)
研究概览
简要总结
The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.
详细描述
Primary Aim: Compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder.
Primary Hypothesis: The proportion of deep surgical site infections will be lower for patients treated with local Vancomycin powder.
Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who develop deep surgical site infections in study patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder.
Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles between patients treated with local Vancomycin powder will be non-inferior to those treated without local Vancomycin powder.
Secondary Aim #2: Build and validate a risk prediction model for the development of deep surgical site infections in patients treated without local Vancomycin powder. (b) Explore whether the effect of local Vancomycin powder is modified by the predicted risk of infection.
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
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
- 否
入选标准
- •All "high energy" tibial plateau fractures treated operatively with plate and screw fixation.
- •We define "high energy" tibial plateau fractures as patients who are either:
- •Initially treated with an external fixation (with or without limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
- •Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- •Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
- •All "high energy" pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define "high energy" pilon fractures as patients who are either:
- •Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
- •Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- •Any tibial pilon fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
- •Ages 18 to 80 years
- •Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
- •Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- •Patients may have a head injury
- •Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at the initial surgery before randomization.
- •Patients may have other orthopedic and non-orthopaedic injuries.
- •Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.
- •Women and minorities are included
排除标准
- •The study injury: tibial plateau, pilon, is already infected at time of study enrollment.
- •Patient speaks neither English nor Spanish.
- •Patients who have already had definitive fixation prior to enrollment in the study.
- •Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
- •Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
- •Pregnancy.
- •The study injury is a type IIIB or IIIC open fracture.
研究组 & 干预措施
Vancomycin Antibotic Powder
Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.
In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.
干预措施: Vancomycin antibiotic powder (Drug)
结局指标
主要结局
Number of Clinically Significant Deep Surgical Site Infection (SSI)
时间窗: 26 weeks
The main outcome will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. The CDC criteria is currently 3 months for surgical site infection. To help capture more infections the study investigators have moved the time frame back to 6 months. Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS). The study investigators will define deep infections as those that require operative treatment, and superficial infections as those that are treated without operative intervention.
次要结局
- Bacterial Antibiotic Resistance Rate of Infected Participants(26 weeks)
- Identify Risk Factors for Infection(26 weeks)
- Pathogen Type(26 weeks)
- Bacterial Susceptibility and Antimicrobial Resistance(26 weeks)