ICG Fluorescence Imaging in Trauma Patients : ICG Fluorescence Imaging in Trauma Patients

This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion. Primary outcome measure is complication (either infection, recurrent infection or nonunion). Eligible consenting patients will receive standard of care treatment for their fracture or infection including irrigation and debridement of their operative site and/or fracture fixation. After exposure, 0.1 mg/Kg ICG will be injected intravenously and video rate ICG fluorescence images will be acquired 20 seconds before and 4 minutes after the injection, each before and after debridement. A subset of 38 post-fracture complication patients will undergo surgical treatment for their infection in Center of Innovation Surgery (CIS) and have either an intraoperative Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) after exposure but before the ICG injection or a preoperative DCE-MRI. Patients receiving surgery in the CIS will be required to sign an additional CIS-specific consent document. The need for repeat surgical procedure will be left up to the treating surgeon. If repeat procedure is needed, pre- and post-debridement quantitative ICG fluorescence images will be obtained at each procedure. Study participants will be followed at 2 weeks, 6 weeks, 3 months and 6 months from their index study surgery. Complication including index infection, recurrent infection or delaying union/nonunion will be identified at the time of diagnosis and/or during each participants assessment that occurs during routine outpatient clinic visit. Detailed information on the infection including date of diagnosis, participant signs and symptoms, culture test results, method of treatment(s), and date of resolution will be documented.4/23/2020: Study recruitment temporarily halted due to COVID-19.

Medienart:

Klinische Studie

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

ClinicalTrials.gov - (2022) vom: 28. Nov. Zur Gesamtaufnahme - year:2022

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Recruitment Status: Completed
Study Type: Observational
Wounds and Injuries

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: January 28, 2020, Last downloaded: ClinicalTrials.gov processed this data on December 05, 2022, Last updated: December 07, 2022

Study ID:

NCT04245111
D20027

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG003281884