CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
imaging 24 hours following intravenous administration of ICGprocedure
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/NCT04927637
NCT04927637N/ACompleted

A Pilot Study to Evaluate Single Dose Indocyanine Green 24 Hours Prior to Operative Treatment of Orthopaedic Infection

Dartmouth-Hitchcock Medical Center·observational·Posted Jun 16, 2021·Updated Feb 27, 2025

In Brief

An observational study evaluating imaging 24 hours following intravenous administration of ICG for Trauma Injury and Bone Infection. Completed, enrolled 2 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 16, 2021
Enrollment StartAug 13, 2021
Primary CompletionMar 9, 2023
Study CompletionMar 9, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.0 years ago

Interventions

imaging 24 hours following intravenous administration of ICGprocedure

Patients will be administered a single, FDA approved, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. ICG fluorescence images will be acquired By a FDA approved surgical imaging device prior to surgical debridement. The wound will be irrigated as per standard procedure and another ICG fluorescence image will be acquired. The need for repeat debridement or tissue cultures will be left up to the treating surgeon.