Trial Outcomes & Findings for ICG 24h Prior to Operative Treatment of Orthopaedic Infection (NCT NCT04927637)

Last Updated: 2025-02-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2 participants

Primary outcome timeframe

Baseline

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	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 imaging 24 hours following intravenous administration of ICG: 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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ICG 24h Prior to Operative Treatment of Orthopaedic Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orthopedic Infection n=2 Participants 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 imaging 24 hours following intravenous administration of ICG: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	71.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Orthopedic Infection n=2 Participants 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 imaging 24 hours following intravenous administration of ICG: 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.
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

Adverse Events

Orthopedic Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ida Leah Gitajn

Dartmouth Health Orthopaedics

Phone: (603) 650-5133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place