N/A
N=2
ICG 24h Prior to Operative Treatment of Orthopaedic Infection
Trauma Injury · Bone Infection
Bottom Line
View on ClinicalTrials.gov: NCT04927637 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data — 0 Percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- imaging 24 hours following intravenous administration of ICG (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Design Feasibility for Preoperative ICG Perfusion Rate as a Predictability Factor for Infection: Measured as Percentage of Patients With Analyzable Data |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older.
- Extremity fracture.
- Prior definitive fracture management with external fixation, internal fixation, or joint fusion.
- Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management.
- Will have all planned SSI care surgeries performed by a participating surgeon or delegate.
- Provision of informed consent.
Exclusion Criteria
- Fractures of the hand cannot be imaged.
- Iodine allergy.
- Burns at the SSI site.
- Incarceration.
- Expected survival of less than 90 days.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Adults unable to consent or whom do not have a LAR
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT04927637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.