CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Immunofluorescence Imagingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04245111
NCT04245111N/ACompleted

ICG Fluorescence Imaging in Trauma Patients

Dartmouth-Hitchcock Medical Center·observational·Posted Jan 28, 2020·Updated Sep 19, 2024

In Brief

An observational study evaluating Immunofluorescence Imaging for Trauma Injury. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma Injury
CountriesUnited States
CollaboratorsDartmouth College

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 28, 2020
Enrollment StartMay 16, 2019
Primary CompletionNov 23, 2021
Study CompletionNov 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.4 years ago

Interventions

Immunofluorescence Imagingother

Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Pentero or Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.