Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures
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:
- 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?
- Are changes in blood flow identifiable at the operative site post operatively?
- Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
- Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
- 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.
Surgical Wound Dehiscence
Drug: ICG (Indocyanine Green)
|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|
- 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.
|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)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01693484
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71103|
|Principal Investigator:||Todd D Jaeblon, D.O||Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma|