Clinical Investigations
Active Clinical Trials
NCT04245111 ICG Fluorescence Imaging in Trauma Patients
Principal Investigator: Dr. Leah Gitajn
This is 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.
NCT04250558 ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Principal Investigator: Dr. Leah Gitajn
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
NCT04839302 Detection and Delineation of Necrotizing Fasciitis Via a Vascular Perfusion Fluorophore
Principal Investigator: Dr. Eric R. Henderson
This is a prospective observational trial to determine if fluorescence signal intensity changes from a vascular perfusion fluorophore (indocyanine green) are associated with the presence of necrotizing fasciitis. Because of the profound pro-thrombotic effects of necrotizing fasciitis within the subcutaneous tissues, we hypothesize that the administration of ICG and subsequent imaging of a bodily region affected with NF will demonstrate substantially reduced fluorescence compared to the patient's unaffected tissues. If we can demonstrate that ICG fluorescence voids are characteristic of NF, this could potentially lead to a more rapid, and potentially more accurate, diagnosis of NF that would lead to more rapid definitive management and-likely-improved outcomes.
NCT04403204 ICG Fluorescence Imaging in Post-traumatic Infecton
Principal Investigator: Dr. Leah Gitajn
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.
NCT04416412 ICG Fluorescence Imaging in Open Fracture Trauma Patients
(Multicenter Trial involving Brigham and Women's Hospital, University of California, Irvine & University of Maryland, Baltimore)
Principal Investigator: Dr. Leah Gitajn
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.
NCT04927637
ICG 24h Prior to Operative Treatment of Orthopaedic Infection
Principal Investigator: Dr. Leah Gitajn
The focus of this study is to (1) Explore variability in distribution of 24h ICG in bone and soft tissue infection (2) Evaluate the change in 24h ICG distribution from pre to post debridement (3) Preliminarily determine whether 24h ICG has the possibility predict infection / treatment failure. Patients will be administered a single, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. The patient will be prepared and transported to surgery as per routine at Dartmouth-Hitchcock. ICG fluorescence images will be acquired prior to surgical debridement.
NCT04976049
Use of 5-Aminolevulinic Acid to Assess Bone and Tissue Profusion in Orthopaedic Infection Patients
Principal Investigator: Dr. Leah Gitajn
The focus of this study is to explore the variability distribution of 5-Aminolevulinic Acid (ALA)associated with bone and soft tissue perfusion in infection patients, using 5-ALA fluorescence imaging. In additional this study plans to evaluate the change in 5-ALA distribution from pre to post debridement and to preliminarily determine whether an orally administered dose of 20mg/kg 5-ALA can predict recurrent infection/treatment failure.
