Real-time Fluorescence-based Measurement of Bone Perfusion in Post-traumatic Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Number of patients requiring unplanned fracture-related reoperations
研究概览
简要总结
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications.
详细描述
This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion. Primary outcome measure is complication (either infection, recurrent infection or nonunion).
Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement.
A subset of 30 post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document.
The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure.
Study participants will be followed at 2 weeks, 6 weeks, 3 months, 6 months, and one year from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, method of treatment(s), and date of resolution will be documented.
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
- •Established SSI Fracture (Cohort Cohort 1, Group 1)
- •Patients 18 years of age or older.
- •Extremity fracture.
- •Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
- •Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.
- •Will have all fracture care surgeries performed by a participating surgeon or delegate.
- •Provision of informed consent.
- •Subset: DCE-MRI (Cohort 1-1, Group 2)
- •Patients 18 years of age or older.
- •Closed extremity fracture.
- •Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
- •Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- •Provision of informed consent.
排除标准
- •Established SSI Fracture Cohort (Cohort 1, Group 1)
- •Fracture of the hand.
- •Iodine allergy.
- •Received previous surgical debridement to manage the SSI.
- •Incarceration.
- •Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- •Subset: DCE-MRI (Cohort 1-1, Group2)
- •the presence of an electronic implant, such as a pacemaker
- •the presence of a metal implant, such as an aneurysm clip
- •the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
- •A history of allergy to iodides
- •A GFR < 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study
研究组 & 干预措施
Established SSI Fracture Cohort Subset (DCE-MRI)
Patients 18 years of age or older. Extremity fracture. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. Will have all fracture care surgeries performed by a participating surgeon or delegate. Provision of informed consent
干预措施: DCE-MRI (Other)
Established SSI Fracture Cohort
Patients 18 years of age or older. Extremity fracture. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. Will have all fracture care surgeries performed by a participating surgeon or delegate. Provision of informed consent
干预措施: Immunofluorescence Imaging (Other)
Established SSI Fracture Cohort Subset (DCE-MRI)
Patients 18 years of age or older. Extremity fracture. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. Will have all fracture care surgeries performed by a participating surgeon or delegate. Provision of informed consent
干预措施: Immunofluorescence Imaging (Other)
结局指标
主要结局
Number of patients requiring unplanned fracture-related reoperations
时间窗: 1 year
All unplanned reoperations will be documented
Number of patients experiencing post procedure surgical site infections
时间窗: 1 year
Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to one year
次要结局
未报告次要终点
研究者
Ida Leah Gitajn
Physician
Dartmouth-Hitchcock Medical Center