Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

NCT01693484 | Terminated Phase 2 Results

• 1 other identifier: ICGVA-OS CALCIS 2012
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Are changes in blood flow identifiable at the operative site post operatively?
3. 3.Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
4. 4.Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
5. 5.Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication?

Conditions

Fractures, Comminuted; Surgical Wound Dehiscence; Necrosis

Keywords

Calcaneus; Fracture; Indocyanine Green; Angiography; Open Reduction and Internal Fixation

Outcome Measures

Primary Outcomes (1)

• Perfusion Data Infection Wound Healing Complication

  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

  3 months postoperative

Study Arms (1)

ICG administered

EXPERIMENTAL

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)

Interventions

ICG (Indocyanine Green) DRUG

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.

Also known as: NDC # 75874-0701-25

ICG administered

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Fractures, Comminuted; Surgical Wound Dehiscence; Necrosis; Fractures, Bone

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Todd Jaeblon
• Organization: LSU Health Science Center Shreveport

tjaebl@lsuhsc.edu

318 675 6180

Study Officials

• Todd D Jaeblon, D.O

  Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery; Associate Director of Othopaedic Trauma

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 26, 2012
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 20, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)