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Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

This study has been terminated.
(Resource availability)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693484
First Posted: September 26, 2012
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Todd Jaeblon, Louisiana State University Health Sciences Center Shreveport
  Purpose

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.


Condition Intervention Phase
Fractures, Comminuted Surgical Wound Dehiscence Necrosis Drug: ICG (Indocyanine Green) Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures Requiring Extensile Lateral Incision

Resource links provided by NLM:


Further study details as provided by Todd Jaeblon, Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Perfusion Data Infection Wound Healing Complication [ Time Frame: 3 months postoperative ]
    correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture


Enrollment: 13
Study Start Date: April 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICG administered
The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes.
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.
Other Name: NDC # 75874-0701-25

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons 18-65 years of age with closed unilateral operative Calcaneus fractures that may be approached by an extended lateral incision

Exclusion Criteria:

  • Patients declining participation
  • Patients with vascular disease or injury requiring vascular repair
  • Patients that have undergone prior ankle or hindfoot surgery
  • Patients with additional hindfoot injury or injuries
  • Patients with open calcaneal fracture
  • Patients with head injury
  • Patients with injury greater than 3 weeks old
  • Patients who are pregnant or currently nursing
  • Patients who are incapable of personally understanding the informed consent document due to mental incapacitation or inability to speak and understand English.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693484


Locations
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Investigators
Principal Investigator: Todd D Jaeblon, D.O Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma
  More Information

Responsible Party: Todd Jaeblon, Associate Professor of Orthopaedic Surgery; Associate Director of Othopaedic Trauma, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01693484     History of Changes
Other Study ID Numbers: ICGVA-OS CALCIS 2012
First Submitted: September 20, 2012
First Posted: September 26, 2012
Results First Submitted: March 6, 2017
Results First Posted: May 24, 2017
Last Update Posted: June 20, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Todd Jaeblon, Louisiana State University Health Sciences Center Shreveport:
Calcaneus
Fracture
Indocyanine Green
Angiography
Open Reduction and Internal Fixation

Additional relevant MeSH terms:
Fractures, Bone
Necrosis
Surgical Wound
Surgical Wound Dehiscence
Fractures, Comminuted
Wounds and Injuries
Pathologic Processes
Postoperative Complications