ICG 24h Prior to Operative Treatment of Orthopaedic Infection

NCT04927637 | Completed Results

• 1 other identifier: STUDY02000989
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma Injury; Bone Infection

Keywords

ICG; Infection; Orthopedics; fluorescence imaging

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline

Study Arms (1)

Orthopedic Infection

Subjects who have undergone previous orthopaedic trauma surgery and have developed and infection will be assessed for protocol inclusion criteria. Patients who meet all inclusion criteria and no exclusion criteria will be administered a single dose 2.5-5 mg/kg ICG dose intravenously ideally 24h prior to surgical debridement. Fluorescent images will be obtained pre and post irrigation and debridement

Procedure: imaging 24 hours following intravenous administration of ICG

Interventions

imaging 24 hours following intravenous administration of ICG PROCEDURE

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.

Orthopedic Infection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 who have been diagnosed with an infection following orthopaedic trauma

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Accidental Injuries; Infections

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Limitations and Caveats

Due to low enrollment rates we were unable to provide significant results for the primary outcome.

Results Point of Contact

• Title: Dr. Ida Leah Gitajn
• Organization: Dartmouth Health Orthopaedics

Ida.Leah.Gitajn@hitchcock.org

(603) 650-5133

Study Officials

• Ida L Gitajn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedics

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: August 13, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2024
• Last Updated: February 27, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)