Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04927637
Study type Observational
Source Dartmouth-Hitchcock Medical Center
Contact
Status Active, not recruiting
Phase
Start date August 13, 2021
Completion date March 9, 2024

See also
  Status Clinical Trial Phase
Completed NCT04567901 - GNRI and Influence of Nutrition on the Mortality of Trauma Patients
Enrolling by invitation NCT05794165 - Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism Phase 2
Not yet recruiting NCT06326827 - In'Oss™ (MBCP® Putty) Ortho
Recruiting NCT04403204 - ICG Fluorescence Imaging in Post-traumatic Infection
Completed NCT04913402 - Sufentanil Used by Paramedics to Treat Pain in Acute Trauma
Not yet recruiting NCT06070350 - Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children Phase 3
Recruiting NCT05616130 - Pathological Myeloid Activation After Sepsis and Trauma
Completed NCT05628519 - Captain Sonar Impact on Trauma Patient Management N/A
Recruiting NCT04907240 - Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Recruiting NCT06123104 - Assessment of Automatic Tourniquets for Soldiers During Wartime N/A
Recruiting NCT05865327 - UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture N/A
Completed NCT05175872 - Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit
Not yet recruiting NCT04387305 - Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study Phase 3
Recruiting NCT04416412 - ICG Fluorescence Imaging in Open Fracture Trauma Patients
Completed NCT04080479 - Bolus Versus Continuous Enteral Tube Feeding N/A
Completed NCT04030832 - Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
Active, not recruiting NCT06063434 - Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game N/A
Not yet recruiting NCT04954768 - Epidemiological Characteristics of Elderly Trauma Patients in Zhejiang Province and Development of Geriatric Trauma Short-term Mortality Prediction Model
Completed NCT04327895 - Surgery in Context of Terrorist Attack : a Survey of French Surgeons
Completed NCT03888703 - The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation N/A