A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 26
- 主要终点
- Study injury related surgical interventions by 1 year
研究概览
简要总结
The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks.
Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2.
Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery >2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other.
Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2.
Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2.
Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2.
Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2.
Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any fractures of any bone at or proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding the spine, treated with any type of internal fixation, or
- •Patients undergoing fusion of any bone at or proximal to and including the subtalar joint or radial carpal joint, (excluding the spine) that develop a post op wound infection at any time.
- •Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
- •Deep culture positive after operative debridement.
- •Cultures positive in thio only after operative debridement.
- •Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
- •Patients who are English or Spanish competent.
- •Patients aged 18 -
- •Patients with bacteria susceptible to both PO and IV antibiotics.
- •Patients able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
- •Patients may have multiple eligible study-eligible injuries.
- •Patients may have temporary external fixation prior to definitive fixation.
- •Patients may have received antibiotics prior to operative wound debridement.
- •Patient is able to obtain study medication(s).
- •Patient may be pregnant at the time of screening.
排除标准
- •Patients who have high risk of amputation of the study limb (based on opinion of the initial managing physician).
- •Patients undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
- •Patients with history of chronic infection at the site of study injury, defined as:
- •patients with chronic osteomyelitis identified by radiographic erosion or sequestrum; or patients with more than one instance of surgical treatment of infection and approximately 6 week course of antibiotics.
- •Patients with pathological fractures; a known history of Paget's disease.
- •Patients for whom the definitive treatment of the study injury was an external fixator.
- •Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
- •Patients with cultures positive in thio only.
- •Patients who are incarcerated or who have unstable housing situations due to concerns regarding ability to receive home care, adherence phone calls, and maintain follow up. .
- •Patients or designated proxy who are unwilling to provide consent.
- •Patients with a history of IV drug use who in the investigator's opinion are unsuitable candidates for IV therapy.
- •Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area.
- •Patients with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol.
- •Patients unable to swallow oral medications or without adequately functioning GI tract.
- •Patients who, based upon the clinical judgment of the treating clinician, are NOT equally suited for treatment with either oral or intravenous antibiotics (i.e., those for whom there is a clinical treatment preference).
结局指标
主要结局
Study injury related surgical interventions by 1 year
时间窗: 1 year
次要结局
- Healthcare costs(1 year)
- Satisfaction with treatment(1 year)
- Treatment Failure by 1 year(1 year)
- Re-hospitalizations by 1 year(1 year)
- Medication Adherence(1 year)