Study of ICG Fluorescence Imaging in Open Fracture and Infection Patients

Not yet recruiting

• Conditions: Fractures, Bone; Trauma Injury
• Interventions: Drug: Immunofluorescence Imaging

• Registration Number: NCT06793644
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Established SSI Fracture Cohort	Immunofluorescence Imaging	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
Open Fracture Cohort	Immunofluorescence Imaging	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who undergo an unplanned fracture-related reoperation	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	12 Months	Post-procedure surgical site infection using Centers for Disease Control criteria will be documented at each follow-up

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States