Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery (OXYGEN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,171
- 试验地点
- 4
- 主要终点
- Surgical Site Infection
研究概览
简要总结
The OXYGEN Study is a double blinded prospective randomized controlled trial that will compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
详细描述
Primary Objective
To compare the proportion of surgical site infections within 6 months in patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
Secondary Objectives
To compare species and antibacterial sensitivities of the bacteria in the patients who develop surgical site infections in study patients treated with Supplemental Perioperative Oxygen compared to those treated without Supplemental Perioperative Oxygen.
To validate the previously developed risk prediction model for the development of surgical site infections after fracture surgery
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
- Quadruple (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
- 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 and treated more than 7 days later after swelling has resolved.
- •Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
- •All "high energy" pilon (distal tibial plafond) 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 fibula fixation or limited internal fixation) and treated definitively more than 7 days later after swelling has resolved.
- •Gustilo Type I, II, and IIIA open fracture, regardless of timing of definitive treatment.
- •All "high energy" calcaneus fractures treated operatively with plate and screw fixation in a staged fashion. We define "high energy" calcaneus fractures as patients who are either:
- •Treated definitively more than 7 days later after swelling has resolved.
- •Gustilo Type Type I, II, and IIIA [30,31] open fracture, regardless of timing of definitive treatment.
- •Ages 18 to 80 years
- •Patients may have co-existing infection not at study fracture site, 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 be treated initially with a temporary external fixator prior to randomization.
- •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 any initial surgery before randomization for definitive fixation.
- •Patients may have other orthopedic and non-orthopaedic injuries.
- •Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.
排除标准
- •Tibial plateau, pilon, or calcaneus already infected at time of study enrollment.
- •Type IIIB, or IIIC open [30,31] fractures
- •Patient speaks neither English nor Spanish.
- •Transfer patients who have already had definitive fixation.
- •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 who are intubated at the time of consent.
- •Patients whose oxygen requirements at the time of surgery would prevent them from participating in either study group will be excluded.
- •History of COPD or any other chronic respiratory disease that renders the patient oxygen dependent at baseline.
- •Current or history of Bleomycin use (chemotherapy use associated with oxygen toxicity).
- •Patient is currently pregnant.
结局指标
主要结局
Surgical Site Infection
时间窗: 26 weeks
The main outcome measure will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. 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).
次要结局
- Catalog and Compare Bacterial Species(26 weeks)
- Risk Factors for Infection(26 weeks)
- Resource Utilization and Cost(1 year)