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NCT04927637

ICG 24h Prior to Operative Treatment of Orthopaedic Infection

Completed Results posted Last updated 27 February 2025
What this trial tests

trial testing imaging 24 hours following intravenous administration of ICG in Trauma Injury in 2 participants. Completed in 9 March 2024.

Timeline
13 August 2021
Primary endpoint
9 March 2023
9 March 2024

Quick facts

Lead sponsorDartmouth-Hitchcock Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2
Start date13 August 2021
Primary completion9 March 2023
Estimated completion9 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

Adults 18 to 100, any sex, with Trauma Injury or Bone Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data Primary · Baseline

This pilot study's objective is to preliminarily determine the study design feasibility of using a single dose of ICG given 24h preoperatively to predict recurrent infection/treatment failure. ICG Perfusion rates within the surgical site will be utilized to assess if there are any predictive measures that would indicate a higher risk of infection. Outcome measure is defined as the percentage of subjects with analyzable data.

GroupValue95% CI
Orthopedic Infection0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Trauma Injury

Currently open trials in the same condition.

Other Dartmouth-Hitchcock Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04927637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing