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Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

NCT01693484 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-06-20

Study results available
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Summary

Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research study are to effectively answer as many of the following research questions as possible:

1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue transfer be used to identify altered patterns of blood flow at the operative site of Calcaneus fractures, when compared to the uninjured extremity?
2. Are changes in blood flow identifiable at the operative site post operatively?
3. Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
4. Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
5. Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication?

The hypothesis is that the study drug will show a correlation between certain patterns of blood flow and whatever post-operative complications may arise.

Conditions

  • Fractures, Comminuted
  • Surgical Wound Dehiscence
  • Necrosis

Interventions

DRUG

ICG (Indocyanine Green)

Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency.

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    lead OTHER

Principal Investigators

  • Todd D Jaeblon, D.O · Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693484 on ClinicalTrials.gov