Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called Near-Infrared Fluorescence (NIRF) imaging to help doctors better assess the health of tissues and bones during surgery for traumatic injuries. Currently, when surgeons check if the tissue is healthy or not, it often relies on their own judgment, which can lead to mistakes and the need for additional surgeries. By using a special dye called Indocyanine Green (ICG), the study aims to see if this new method can provide clearer information about which areas of tissue are alive and which are not, potentially improving treatment outcomes and reducing hospital stays.

To participate in this study, individuals must be at least 18 years old and have specific types of injuries, such as serious fractures or infections that require surgery. However, some people may not be eligible, including those with certain health conditions or those who are pregnant. Participants can expect to be involved in a surgical procedure where this new imaging technique will be tested, helping doctors make better decisions during their treatment. This trial is currently recruiting participants, and it aims to improve care for patients dealing with traumatic injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, a subject must meet all the following criteria:
• • Age ≥ 18 years
• * Diagnosed with one or more of the following injuries:
• • Crush injury
• • Open deglovement
• • Open fracture(s) (Gustilo 3, -A, -B \& -C)
• • Non-union tibia/clavicula/ulna/humerus/rib
• • Fracture related infection
• • Indication for surgical intervention
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • Hemodynamically unstable due to severe blood loss
• • Allergic or hypersensitive to iodine/crustaceans/shellfish
• • Diagnosed with endocrine thyroid disorders (hyperthyroidism)
• • Pregnancy
• • Diagnosed with impaired renal function eGFR \<30 L/min/1.73m2
• • Diagnosed with severely disturbed hepatic enzymes/liver failure