Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Louisiana State University Health Sciences Center Shreveport
Sponsor:
Information provided by (Responsible Party):
Todd Jaeblon, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01693484
First received: September 20, 2012
Last updated: September 12, 2014
Last verified: September 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • a statistically relevant correlation between operative site perfusion patterns and development of wound healing complications post operatively. [ Time Frame: 12 weeks post operatively per patient ] [ Designated as safety issue: Yes ]
    When 13 patients have enrolled and data collection has been finalized, if the statistician does not believe there is enough data to identify a statistically significant correlation, then the study will continue until 21 subjects have been enrolled. If at this time, there is still an inadequate amount of data for statistical significance, the study will continue until 28 subjects are enrolled. If, in the statistician's opinion, an intermediate value of subjects between the numbers given above will suffice for showing statistical significance, that will be the number enrolled. Every effort will be made to ensure that no more subjects will be enrolled than the minimum necessary to show statistical significance.


Estimated Enrollment: 28
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693484

Contacts
Contact: Todd D Jaeblon, D.O 318.675.6180 tjaebl@lsuhsc.edu

Locations
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Todd D Jaeblon, D.O    318-675-6180    tjaebl@lsuhsc.edu   
Principal Investigator: Todd D Jaeblon, D.O         
Sub-Investigator: David A Alvarez, M.D         
Sub-Investigator: John V Marymont, M.D, M.B.A         
Sub-Investigator: Shane F Strom, B.A         
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

No publications provided

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
Study First Received: September 20, 2012
Last Updated: September 12, 2014
Health Authority: United States: Louisiana State University Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014