<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01693484</url>
  </required_header>
  <id_info>
    <org_study_id>ICGVA-OS CALCIS 2012</org_study_id>
    <nct_id>NCT01693484</nct_id>
  </id_info>
  <brief_title>Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures</brief_title>
  <official_title>Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures Requiring Extensile Lateral Incision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center Shreveport</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center Shreveport</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to&#xD;
      learn if patterns of blood-flow around the incision site of patients undergoing surgery for&#xD;
      heel-bone fractures can help predict whether complications will arise after a specific type&#xD;
      of operation.The goals of this research study are to effectively answer as many of the&#xD;
      following research questions as possible:&#xD;
&#xD;
        1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue&#xD;
           transfer be used to identify altered patterns of blood flow at the operative site of&#xD;
           Calcaneus fractures, when compared to the uninjured extremity?&#xD;
&#xD;
        2. Are changes in blood flow identifiable at the operative site post operatively?&#xD;
&#xD;
        3. Are there certain patterns of blood flow present preoperatively or postoperatively that&#xD;
           can predict wound complication?&#xD;
&#xD;
        4. Can certain patterns of blood flow predict the location of slough or dehiscence after&#xD;
           surgery?&#xD;
&#xD;
        5. Does the incision site and its proximity to specific patterns of blood flow possibly&#xD;
           predict wound complication?&#xD;
&#xD;
      The hypothesis is that the study drug will show a correlation between certain patterns of&#xD;
      blood flow and whatever post-operative complications may arise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fractures of the calcaneus comprise 2% of all adult fractures. These fractures make up 60% of&#xD;
      all tarsal injuries, the majority of which are closed, displaced intra-articular fractures.&#xD;
      Despite the injury's prevalence, dispute over the appropriate method of treatment remains&#xD;
      ongoing. Several studies have shown that an open, surgical approach is superior to either a&#xD;
      non-surgical or percutaneous approach with regard to restoring proper alignment and structure&#xD;
      of the hindfoot, depending on the severity of the displacement, and provided that certain&#xD;
      patient conditions do not preclude surgery. Adequately restoring hindfoot structure is&#xD;
      paramount to good clinical outcome; not only is proper alignment integral for fully&#xD;
      recovering physiological functionality, but also in preventing further complications such as&#xD;
      subtalar arthritis that present commonly in malunited calcaneal fractures.&#xD;
&#xD;
      Though literature may show that open reduction and internal fixation (ORIF) techniques&#xD;
      provide a better long term outcome of severely displaced intra-articular fractures,&#xD;
      proponents of both non surgical and percutaneous approaches argue that the superiority of the&#xD;
      outcome may be mitigated by the fact that open surgical procedures are laden post operatively&#xD;
      with numerous wound complications. These complications include, but are not limited to, both&#xD;
      deep and superficial infections resulting in slough, dehiscence, necrosis, and erythema in&#xD;
      and around the surgical site. Managing infections of the surrounding soft tissue and&#xD;
      vasculature of the calcaneus following operative treatment indeed seems to present a great&#xD;
      challenge to treating physicians, with wound healing complications present in 2-25% of cases.&#xD;
&#xD;
      A necessity for surgical wound repair is adequately vascularized tissue, which can be&#xD;
      difficult to come by during closure of the wound due to the undermining and displacement of&#xD;
      soft tissue during surgery. Sufficiently perfused soft tissue can also be difficult to&#xD;
      differentiate from tissues that are inadequately vascular based on traditional clinical&#xD;
      criteria such as color, warmth, and dermal bleeding. The degree of this avascularity can&#xD;
      depend on many factors relating to the patient, necessitating studies be conducted&#xD;
      identifying what factors place a prospective patient at a higher risk for developing wound&#xD;
      healing problems post operatively. Studies of this nature thus far have noted that factors&#xD;
      such as age, sex, height, weight, Bohler's angle, tobacco usage, and pre-existing conditions&#xD;
      such as diabetes, vascular disease, and immune deficiencies may be indicative of increased&#xD;
      likelihood for developing post surgical complications. Another risk factor of particular&#xD;
      interest is the timing of surgery after the incidence of injury. Current literature regarding&#xD;
      treatment of hindfoot injuries shows a moderate degree of uniformity, advocating a delay in&#xD;
      operative measures until the soft tissue swelling around the injury has had time to subside:&#xD;
      a window of approximately 7-14 days after injury. Additionally, in their investigation of&#xD;
      Bohler's angle as a predictor for wound healing complications, Shuler and colleagues noted&#xD;
      the pre and post operative Bohler's angle differential to be a significant predictor of&#xD;
      developing infections, postulating that the increase in heel height during surgery may&#xD;
      concomitantly increase soft tissue tension substantially enough to disrupt proper blood&#xD;
      supply to the surgical site during healing. These findings lend tremendous support to the&#xD;
      idea that blood perfusion in soft tissue plays a significant role in predicting wound healing&#xD;
      complications. However, to our knowledge, the use of angiography to correlate pre and post&#xD;
      operative soft tissue perfusion patterns with post operative complication in patients&#xD;
      undergoing ORIF of fractured calcanei has never been investigated.&#xD;
&#xD;
      Indocyanine green (ICG) angiography has been utilized in a myriad of other fields of medicine&#xD;
      to evaluate perfusion in different tissues. It has been used in cardiac surgery to asses&#xD;
      bypass patency, in microsurgery to assist in free tissue transfers, and in plastic surgery to&#xD;
      assess areas of future necrosis during mastectomy operations. Recently, ICG angiography has&#xD;
      been used in general surgery to detect ischemic tissues and aid surgeons in determining the&#xD;
      appropriate extent of debridement necessary prior to wound closure in laparotomy procedures.&#xD;
      Though its utility in other disciplines of medicine are currently being further developed and&#xD;
      understood, the implications of ICG angiography in orthopaedic surgery have gone&#xD;
      unrecognized. We postulate that soft-tissue perfusion patterns elucidated by ICG angiography&#xD;
      in the heels of patients that have incurred calcaneal fractures may be predictive of wound&#xD;
      healing complications that develop after surgery. This information could allow surgeons to&#xD;
      greatly reduce the complication rate of open reduction procedures on calcaneus fractures by&#xD;
      early utilization of appropriate, patient specific prophylactic measures, and could provide&#xD;
      an additional contraindication to this operation for patients whom otherwise were not aware&#xD;
      they are at an elevated risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Resource availability&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perfusion Data Infection Wound Healing Complication</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Fractures, Comminuted</condition>
  <condition>Surgical Wound Dehiscence</condition>
  <condition>Necrosis</condition>
  <arm_group>
    <arm_group_label>ICG administered</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICG (Indocyanine Green)</intervention_name>
    <description>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.</description>
    <arm_group_label>ICG administered</arm_group_label>
    <other_name>NDC # 75874-0701-25</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons 18-65 years of age with closed unilateral operative Calcaneus fractures that&#xD;
             may be approached by an extended lateral incision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients declining participation&#xD;
&#xD;
          -  Patients with vascular disease or injury requiring vascular repair&#xD;
&#xD;
          -  Patients that have undergone prior ankle or hindfoot surgery&#xD;
&#xD;
          -  Patients with additional hindfoot injury or injuries&#xD;
&#xD;
          -  Patients with open calcaneal fracture&#xD;
&#xD;
          -  Patients with head injury&#xD;
&#xD;
          -  Patients with injury greater than 3 weeks old&#xD;
&#xD;
          -  Patients who are pregnant or currently nursing&#xD;
&#xD;
          -  Patients who are incapable of personally understanding the informed consent document&#xD;
             due to mental incapacitation or inability to speak and understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd D Jaeblon, D.O</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center - Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>March 6, 2017</results_first_submitted>
  <results_first_submitted_qc>April 17, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2017</results_first_posted>
  <last_update_submitted>May 23, 2017</last_update_submitted>
  <last_update_submitted_qc>May 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center Shreveport</investigator_affiliation>
    <investigator_full_name>Todd Jaeblon</investigator_full_name>
    <investigator_title>Associate Professor of Orthopaedic Surgery; Associate Director of Othopaedic Trauma</investigator_title>
  </responsible_party>
  <keyword>Calcaneus</keyword>
  <keyword>Fracture</keyword>
  <keyword>Indocyanine Green</keyword>
  <keyword>Angiography</keyword>
  <keyword>Open Reduction and Internal Fixation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
    <mesh_term>Fractures, Comminuted</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Displaced Intra Articular Calcaneus Fracture</title>
          <description>displaced intra articular calcaneus fracture with operative repair</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Study closed by PI</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Operative Calcaneus Fracture</title>
          <description>Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Perfusion Data Infection Wound Healing Complication</title>
        <description>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</description>
        <time_frame>3 months postoperative</time_frame>
        <population>unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients</population>
        <group_list>
          <group group_id="O1">
            <title>ICG Administered</title>
            <description>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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Perfusion Data Infection Wound Healing Complication</title>
          <description>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</description>
          <population>unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Unanticipated Adverse Events Related to ICG</title>
          <description>No adverse events related to administration ICG</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>wound healing delay</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Todd Jaeblon</name_or_title>
      <organization>LSU Health Science Center Shreveport</organization>
      <phone>318 675 6180 ext 419</phone>
      <email>tjaebl@lsuhsc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01693484
org study id: ICGVA-OS CALCIS 2012
nct id: NCT01693484
lead sponsor: 
has dmc: No
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.
Fractures of the calcaneus comprise 2% of all adult fractures. These fractures make up 60% of
      all tarsal injuries, the majority of which are closed, displaced intra-articular fractures.
      Despite the injury's prevalence, dispute over the appropriate method of treatment remains
      ongoing. Several studies have shown that an open, surgical approach is superior to either a
      non-surgical or percutaneous approach with regard to restoring proper alignment and structure
      of the hindfoot, depending on the severity of the displacement, and provided that certain
      patient conditions do not preclude surgery. Adequately restoring hindfoot structure is
      paramount to good clinical outcome; not only is proper alignment integral for fully
      recovering physiological functionality, but also in preventing further complications such as
      subtalar arthritis that present commonly in malunited calcaneal fractures.

      Though literature may show that open reduction and internal fixation (ORIF) techniques
      provide a better long term outcome of severely displaced intra-articular fractures,
      proponents of both non surgical and percutaneous approaches argue that the superiority of the
      outcome may be mitigated by the fact that open surgical procedures are laden post operatively
      with numerous wound complications. These complications include, but are not limited to, both
      deep and superficial infections resulting in slough, dehiscence, necrosis, and erythema in
      and around the surgical site. Managing infections of the surrounding soft tissue and
      vasculature of the calcaneus following operative treatment indeed seems to present a great
      challenge to treating physicians, with wound healing complications present in 2-25% of cases.

      A necessity for surgical wound repair is adequately vascularized tissue, which can be
      difficult to come by during closure of the wound due to the undermining and displacement of
      soft tissue during surgery. Sufficiently perfused soft tissue can also be difficult to
      differentiate from tissues that are inadequately vascular based on traditional clinical
      criteria such as color, warmth, and dermal bleeding. The degree of this avascularity can
      depend on many factors relating to the patient, necessitating studies be conducted
      identifying what factors place a prospective patient at a higher risk for developing wound
      healing problems post operatively. Studies of this nature thus far have noted that factors
      such as age, sex, height, weight, Bohler's angle, tobacco usage, and pre-existing conditions
      such as diabetes, vascular disease, and immune deficiencies may be indicative of increased
      likelihood for developing post surgical complications. Another risk factor of particular
      interest is the timing of surgery after the incidence of injury. Current literature regarding
      treatment of hindfoot injuries shows a moderate degree of uniformity, advocating a delay in
      operative measures until the soft tissue swelling around the injury has had time to subside:
      a window of approximately 7-14 days after injury. Additionally, in their investigation of
      Bohler's angle as a predictor for wound healing complications, Shuler and colleagues noted
      the pre and post operative Bohler's angle differential to be a significant predictor of
      developing infections, postulating that the increase in heel height during surgery may
      concomitantly increase soft tissue tension substantially enough to disrupt proper blood
      supply to the surgical site during healing. These findings lend tremendous support to the
      idea that blood perfusion in soft tissue plays a significant role in predicting wound healing
      complications. However, to our knowledge, the use of angiography to correlate pre and post
      operative soft tissue perfusion patterns with post operative complication in patients
      undergoing ORIF of fractured calcanei has never been investigated.

      Indocyanine green (ICG) angiography has been utilized in a myriad of other fields of medicine
      to evaluate perfusion in different tissues. It has been used in cardiac surgery to asses
      bypass patency, in microsurgery to assist in free tissue transfers, and in plastic surgery to
      assess areas of future necrosis during mastectomy operations. Recently, ICG angiography has
      been used in general surgery to detect ischemic tissues and aid surgeons in determining the
      appropriate extent of debridement necessary prior to wound closure in laparotomy procedures.
      Though its utility in other disciplines of medicine are currently being further developed and
      understood, the implications of ICG angiography in orthopaedic surgery have gone
      unrecognized. We postulate that soft-tissue perfusion patterns elucidated by ICG angiography
      in the heels of patients that have incurred calcaneal fractures may be predictive of wound
      healing complications that develop after surgery. This information could allow surgeons to
      greatly reduce the complication rate of open reduction procedures on calcaneus fractures by
      early utilization of appropriate, patient specific prophylactic measures, and could provide
      an additional contraindication to this operation for patients whom otherwise were not aware
      they are at an elevated risk.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Perfusion Data Infection Wound Healing Complication
time frame: 3 months postoperative
description: 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
arm group label: ICG administered
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: ICG (Indocyanine Green)
description: 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.
arm group label: ICG administered
other name: NDC # 75874-0701-25
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Todd D Jaeblon, D.O
role: Principal Investigator
affiliation: Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center Shreveport
investigator full name: Todd Jaeblon
investigator title: Associate Professor of Orthopaedic Surgery; Associate Director of Othopaedic Trauma
mesh term: Necrosis
mesh term: Surgical Wound Dehiscence
mesh term: Fractures, Bone
mesh term: Surgical Wound
mesh term: Fractures, Comminuted
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 