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 DataPrimary· 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.
Group
Value
95% CI
Orthopedic Infection
0
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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Sponsor: as reported to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center
Last refreshed: 27 February 2025
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.