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Imaging

Intraoperative Fluorescence Angiography for Open Fractures

N/A
Waitlist Available
Led By Jed I Maslow, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Open type II or type III upper or lower extremity fracture to be treated at Vanderbilt University Medical Center with operative intervention by orthopaedic trauma or orthopaedic hand surgeons.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights

Study Summary

This trial will test whether using a fluorescent dye to make blood vessels more visible during surgery can help surgeons more effectively remove dead tissue in orthopedic trauma patients.

Who is the study for?
Adults over 18 with severe open fractures in arms or legs, who are getting surgery at Vanderbilt University Medical Center. Not for those in critical condition needing urgent care, allergic to indocyanine green dye, under 18, or pregnant.Check my eligibility
What is being tested?
The study is testing if a technique called intraoperative fluorescence angiography (IFA) can help surgeons see blood flow better during the cleaning of severe fractures during surgery.See study design
What are the potential side effects?
Potential side effects may include reactions to the indocyanine green dye used in IFA such as allergy symptoms. Since this is a diagnostic procedure, fewer side effects are expected compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a severe arm or leg fracture needing surgery at Vanderbilt.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Additional debridement following IFA use

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative fluorescence angiographyExperimental Treatment1 Intervention
Intraoperative fluorescence angiography will be utilized to view initial debridement area. Using a sterile marking pen, the surgeon will mark the areas of tissue on skin, subcutaneous tissue, muscle, bone, or other that he or she wishes to debride further due to poor perfusion. A reference point on uninjured tissue of the same extremity at least 10 cm from the wound will be identified and measured for perfusion (set to reference of 100% perfusion). The area to be further debrided will be measured for percent perfusion relative to this reference point.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,172 Total Patients Enrolled
Jed I Maslow, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Intraoperative Fluorescence Angiography (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05006313 — N/A
Intraoperative Fluorescence Angiography Research Study Groups: Intraoperative fluorescence angiography
Intraoperative Fluorescence Angiography Clinical Trial 2023: Intraoperative Fluorescence Angiography Highlights & Side Effects. Trial Name: NCT05006313 — N/A
Intraoperative Fluorescence Angiography (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006313 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still active for this research?

"This medical trial, which was initially added to clinicaltrials.gov on July 1st 2023, is not actively recruiting patients due to a recent update made November 2nd 2022. Although this study is no longer enrolling participants, there are 15 other studies with open enrolment at present."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Vanderbilt Orthopaedics
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Intraoperative Fluorescence Angiography in Debridement of Open Fractures
Jed Maslow 2024. "Intraoperative Fluorescence Angiography in Debridement of Open Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006313.
~13 spots leftby Oct 2024
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