Overview

Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
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.