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NCT04927637 · ClinicalTrials.gov registry record
ICG 24h Prior to Operative Treatment of Orthopaedic Infection
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- 2
- Enrollment target
NCT04927637: Completed study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04927637 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04927637 has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE imaging 24 hours following intravenous administration of ICG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2024-03-09 |
What the finished NCT04927637 record still lists
NCT04927637 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which imaging 24 hours following intravenous administration of ICG is the first listed.
NCT04927637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04927637 about?
NCT04927637 is a clinical study titled "ICG 24h Prior to Operative Treatment of Orthopaedic Infection". 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. Patie...
What is the current status of trial NCT04927637?
This trial is currently completed. The enrollment target is 2 participants. The study started on 2021-08-13. Estimated completion is 2024-03-09.
What interventions are being tested in trial NCT04927637?
The interventions under investigation include: imaging 24 hours following intravenous administration of ICG (PROCEDURE).
Who is sponsoring clinical trial NCT04927637?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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