Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04927637 |
Other study ID # |
STUDY02000989 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 13, 2021 |
Est. completion date |
March 9, 2024 |
Study information
Verified date |
November 2023 |
Source |
Dartmouth-Hitchcock Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Infection following trauma is one of the most prevalent and challenging complications faced
by orthopedic surgeons in both military and civilian populations, occurring after up to 60%
of open bone fractures. Several factors specific to this trauma place patients at high risk
for infectious complications, including: traumatized tissues, open contaminated fracture,
soft tissue coverage issues, catabolic state due to poly-trauma, prolonged hospitalization
with exposure to nosocomial bacteria, and presence of metallic implants8. Infection requires
one or more unplanned surgical procedures and leads to prolonged morbidity, loss of function,
and potential loss of limb. Failed treatment for bone infection results in recurrent
infection, requiring repeat surgical procedures in approximately 30% of patients.
Infection is known to display the enhanced permeability and retention effect with increased
vascular permeability. Second window or 24h ICG represents an ideal method to identify these
areas of increased vascular permeability. In some instances infected tissue can be hard to
distinguish from healthy tissue when ICG is given immediately before optical imaging Second
window ICG will allow surgeons to better distinguish infected tissue from healthy tissue as
the ICG will have a better opportunity to permeate the infected tissue while it will have
been expelled from the health tissue.
There are currently no accepted intraoperative tools that can be used to make objective
decisions about which bone and tissue is infected and which is normal. Methods currently used
to guide debridement are quite rudimentary. Clinical judgment is based on the gross
appearance of soft tissue and bone, including color, turgor, and extent of soft tissue
stripping. A burr may be used to look for bleeding bone. More extensive debridement is
thought to minimize risk of index infection or reduce the rate of persistent infection;
however, this comes at the cost of increasingly complex reconstructive procedures to fill
bony defects. Clearly what is needed is a functional imaging system which can identify
infected tissues to guide surgeons in the amount of tissue to debride. In turn, this will
lead to fewer infections and a more effective treatment of SSIs at the fracture site. Both
scenarios will allow patients to return to duty or work sooner.
The study endpoint is to determine the variability of bone and soft tissue perfusion in
infection patients when given a single dose of ICG 24h prior to surgical debridement. The
long term goal of this study is to aid in the development and optimization of bone specific
imaging strategies that can be used to guide debridement and to optimize the quality of bone
/ tissue resection to minimize complications.