Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients (cBPI)

Dartmouth Health

Status: Enrolling

Conditions: Trauma Injury; Fractures, Bone

Treatments: Drug: Immunofluorescence Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT06793644

STUDY02002551

Details and patient eligibility

About

The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older.
• Open extremity fracture, planning for management with external fixation, internal fixation or joint fusion.
• Fracture Related Infection, planning for management with debridement and possible removal of hardware.
• Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
• Provision of informed consent.

Exclusion criteria

• Inability of patient to provide informed consent
• Fracture of the hand.
• Iodine allergy.
• Burns at the fracture site.

Trial design

10 participants in 2 patient groups

Established SSI Fracture Cohort

Description:

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

Treatment:

Drug: Immunofluorescence Imaging

Open Fracture Cohort

Description:

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.

Treatment:

Drug: Immunofluorescence Imaging