Optimizing Surgical Debridement Following High-energy Open Trauma With Dynamic Contrast-enhanced Fluorescence Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 5
- 主要终点
- Number of participants who undergo an unplanned fracture-related reoperation
研究概览
简要总结
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.
详细描述
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older.
- •Open extremity fracture.
- •Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
- •Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
- •Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- •Provision of informed consent.
排除标准
- •Inability of patient to provide informed consent
- •Fracture of the hand.
- •Iodine allergy.
- •Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
- •Open fracture managed outside of the participating orthopaedic service.
- •Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- •Burns at the fracture site.
结局指标
主要结局
Number of participants who undergo an unplanned fracture-related reoperation
时间窗: 12 months
All unplanned reoperations will be documented using a specific case report form
Number of participants who experience a post-procedure surgical site infection
时间窗: 12 months
Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up
次要结局
未报告次要终点
研究者
Ida Leah Gitajn
Physician
Dartmouth-Hitchcock Medical Center