<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/NCT02196779</url>
  </required_header>
  <id_info>
    <org_study_id>Swanson 003</org_study_id>
    <nct_id>NCT02196779</nct_id>
  </id_info>
  <brief_title>Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty</brief_title>
  <official_title>Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swanson Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swanson Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of&#xD;
      complications is reduced by limiting the operative dissection. However, this can compromise&#xD;
      the quality of the result. This study was undertaken to investigate the blood supply of the&#xD;
      abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is&#xD;
      injected and the fluorescence is recorded using a near-infrared laser. The blood supply is&#xD;
      tested after a limited dissection and then after a traditional dissection to determine&#xD;
      whether an extended dissection reduces the skin circulation. The study hypothesis is that&#xD;
      there is no difference in blood supply and the traditional abdominoplasty does not compromise&#xD;
      skin circulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol&#xD;
&#xD;
      Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty.&#xD;
&#xD;
      Background/Purpose&#xD;
&#xD;
      Abdominoplasty (tummy tuck) is a common cosmetic operation. One of the risks of surgery is&#xD;
      delayed wound healing caused by impaired circulation to the skin. In an effort to reduce&#xD;
      risk, some investigators1 advocate a limited-undermining technique, with preservation of the&#xD;
      perforating blood vessels and preservation of the Scarpa fascia of the lower abdomen.&#xD;
      However, there is no evidence that this limited-undermining technique improves blood supply&#xD;
      compared with a traditional abdominoplasty dissection. Such a limited dissection may&#xD;
      compromise the cosmetic result.&#xD;
&#xD;
      This study was undertaken to investigate the blood supply of the abdominal skin during the&#xD;
      abdominoplasty procedure. By testing the circulation at two points during the dissection, and&#xD;
      a third time after completion of the operation, data may be obtained and used to evaluate the&#xD;
      effect of the extent of the dissection on blood supply of the skin flap.&#xD;
&#xD;
      Laser fluorescent imaging represents an objective measurement technique that has been used to&#xD;
      quantitate blood supply in skin flaps and other tissues. It has been used for several years&#xD;
      to monitor the vascularity of flaps used in breast reconstruction. This technique has also&#xD;
      been used previously in patients undergoing abdominoplasty.2&#xD;
&#xD;
      Subjects&#xD;
&#xD;
      Twenty consecutive consenting adult men and women undergoing outpatient elective&#xD;
      abdominoplasty will be investigated using laser fluorescent imaging. By testing the blood&#xD;
      supply at three time points, the patient serves as his or her own control.&#xD;
&#xD;
      Imaging&#xD;
&#xD;
      The SPY Elite Intraoperative Perfusion Assessment System (Lifecell Corp., Branchburg, NJ)&#xD;
      consists of a near-infrared laser that detects fluorescence. The imaging agent, indocyanine&#xD;
      green, is absorbed at this region of the spectrum, 800-810 nm. The imaging agent is injected&#xD;
      intravenously. Starting within 5-10 seconds of injection, the system records images of the&#xD;
      abdomen, showing the fluorescence, which indicates blood supply. The half-life of the imaging&#xD;
      agent is 2.5-3 minutes. The imaging agent is metabolized by the liver. The only known risk is&#xD;
      an allergic reaction to the imaging agent. Patients with a history of an allergic reaction to&#xD;
      iodinated contrast dyes are excluded.&#xD;
&#xD;
      Surgery&#xD;
&#xD;
      The lipoabdominoplasty technique is performed as described by Saldanha et al.1 Following this&#xD;
      limited dissection, 3 mL (7.5 mg) of indocyanine green is injected and the abdominal image is&#xD;
      recorded, documenting blood supply to the lower abdomen. After further dissection, another 3&#xD;
      mL of imaging agent is injected and the lower abdomen is re-imaged. On completion of surgery,&#xD;
      a third injection is administered and a final image is recorded.&#xD;
&#xD;
      Null Hypothesis&#xD;
&#xD;
      A traditional abdominoplasty dissection does not compromise circulation compared with a more&#xD;
      limited dissection technique.&#xD;
&#xD;
      Informed Consent&#xD;
&#xD;
      Patients are informed as to the nature of the study and are told that their participation is&#xD;
      entirely voluntary and they are free to decline, and that doing so does not in any way&#xD;
      prejudice their treatment. Patients are informed of the small risk of an allergic reaction&#xD;
      that will be treated if it occurs.&#xD;
&#xD;
      Patient Risk&#xD;
&#xD;
      There is no patient risk apart from a very small risk of allergic reaction, which is further&#xD;
      reduced by excluding any patient with a known allergy to iodinated contrast dye. The study&#xD;
      does not affect patient treatment. It offers the possibility of detection of reduced skin&#xD;
      circulation, information that can be used by the surgeon to limit the dissection if necessary&#xD;
      and avoid tissue loss and delayed wound healing, known complications of abdominoplasty.&#xD;
&#xD;
      Sample Size&#xD;
&#xD;
      A sample of 20 patients is anticipated, treated over a period of approximately 6 months.&#xD;
&#xD;
      Disclosure&#xD;
&#xD;
      The author has no financial interest in any of the products, devices, or drugs mentioned in&#xD;
      this article. The author has no conflicts of interest to disclose. There was no outside&#xD;
      funding for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Skin circulation during abdominoplasty.</measure>
    <time_frame>6 months</time_frame>
    <description>The blood supply to the skin is evaluated intraoperatively using laser fluorescent imaging.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Abdominal Skin Redundancy</condition>
  <arm_group>
    <arm_group_label>Patients undergoing abdominoplasty</arm_group_label>
    <description>Skin circulation to abdominal flap is evaluated during surgery using laser fluorescent imaging.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult men and women undergoing abdominoplasty.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing abdominoplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to iodinated contrast agents&#xD;
&#xD;
          -  Nonconsenting patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Swanson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swanson Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swanson Center</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Roostaeian J, Harris R, Farkas JP, Barton FE, Kenkel JM. Comparison of Limited-Undermining Lipoabdominoplasty and Traditional Abdominoplasty Using Laser Fluorescence Imaging. Aesthet Surg J. 2014 Jul;34(5):741-7. doi: 10.1177/1090820X14532286. Epub 2014 Jul 1.</citation>
    <PMID>24809360</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>November 18, 2014</last_update_submitted>
  <last_update_submitted_qc>November 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swanson Center</investigator_affiliation>
    <investigator_full_name>Eric Swanson, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Abdominoplasty</keyword>
  <keyword>circulation</keyword>
  <keyword>skin</keyword>
  <keyword>dissection</keyword>
  <keyword>laser</keyword>
  <keyword>fluorescence</keyword>
  <keyword>imaging</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02196779
org study id: Swanson 003
nct id: NCT02196779
lead sponsor: 
has dmc: No
Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of
      complications is reduced by limiting the operative dissection. However, this can compromise
      the quality of the result. This study was undertaken to investigate the blood supply of the
      abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is
      injected and the fluorescence is recorded using a near-infrared laser. The blood supply is
      tested after a limited dissection and then after a traditional dissection to determine
      whether an extended dissection reduces the skin circulation. The study hypothesis is that
      there is no difference in blood supply and the traditional abdominoplasty does not compromise
      skin circulation.
Protocol

      Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty.

      Background/Purpose

      Abdominoplasty (tummy tuck) is a common cosmetic operation. One of the risks of surgery is
      delayed wound healing caused by impaired circulation to the skin. In an effort to reduce
      risk, some investigators1 advocate a limited-undermining technique, with preservation of the
      perforating blood vessels and preservation of the Scarpa fascia of the lower abdomen.
      However, there is no evidence that this limited-undermining technique improves blood supply
      compared with a traditional abdominoplasty dissection. Such a limited dissection may
      compromise the cosmetic result.

      This study was undertaken to investigate the blood supply of the abdominal skin during the
      abdominoplasty procedure. By testing the circulation at two points during the dissection, and
      a third time after completion of the operation, data may be obtained and used to evaluate the
      effect of the extent of the dissection on blood supply of the skin flap.

      Laser fluorescent imaging represents an objective measurement technique that has been used to
      quantitate blood supply in skin flaps and other tissues. It has been used for several years
      to monitor the vascularity of flaps used in breast reconstruction. This technique has also
      been used previously in patients undergoing abdominoplasty.2

      Subjects

      Twenty consecutive consenting adult men and women undergoing outpatient elective
      abdominoplasty will be investigated using laser fluorescent imaging. By testing the blood
      supply at three time points, the patient serves as his or her own control.

      Imaging

      The SPY Elite Intraoperative Perfusion Assessment System (Lifecell Corp., Branchburg, NJ)
      consists of a near-infrared laser that detects fluorescence. The imaging agent, indocyanine
      green, is absorbed at this region of the spectrum, 800-810 nm. The imaging agent is injected
      intravenously. Starting within 5-10 seconds of injection, the system records images of the
      abdomen, showing the fluorescence, which indicates blood supply. The half-life of the imaging
      agent is 2.5-3 minutes. The imaging agent is metabolized by the liver. The only known risk is
      an allergic reaction to the imaging agent. Patients with a history of an allergic reaction to
      iodinated contrast dyes are excluded.

      Surgery

      The lipoabdominoplasty technique is performed as described by Saldanha et al.1 Following this
      limited dissection, 3 mL (7.5 mg) of indocyanine green is injected and the abdominal image is
      recorded, documenting blood supply to the lower abdomen. After further dissection, another 3
      mL of imaging agent is injected and the lower abdomen is re-imaged. On completion of surgery,
      a third injection is administered and a final image is recorded.

      Null Hypothesis

      A traditional abdominoplasty dissection does not compromise circulation compared with a more
      limited dissection technique.

      Informed Consent

      Patients are informed as to the nature of the study and are told that their participation is
      entirely voluntary and they are free to decline, and that doing so does not in any way
      prejudice their treatment. Patients are informed of the small risk of an allergic reaction
      that will be treated if it occurs.

      Patient Risk

      There is no patient risk apart from a very small risk of allergic reaction, which is further
      reduced by excluding any patient with a known allergy to iodinated contrast dye. The study
      does not affect patient treatment. It offers the possibility of detection of reduced skin
      circulation, information that can be used by the surgeon to limit the dissection if necessary
      and avoid tissue loss and delayed wound healing, known complications of abdominoplasty.

      Sample Size

      A sample of 20 patients is anticipated, treated over a period of approximately 6 months.

      Disclosure

      The author has no financial interest in any of the products, devices, or drugs mentioned in
      this article. The author has no conflicts of interest to disclose. There was no outside
      funding for this study.
observational model: Case-Only
time perspective: Prospective
measure: Skin circulation during abdominoplasty.
time frame: 6 months
description: The blood supply to the skin is evaluated intraoperatively using laser fluorescent imaging.
arm group label: Patients undergoing abdominoplasty
description: Skin circulation to abdominal flap is evaluated during surgery using laser fluorescent imaging.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Swanson, M.D.
role: Principal Investigator
affiliation: Swanson Center
facility: 
country: United States
citation: Roostaeian J, Harris R, Farkas JP, Barton FE, Kenkel JM. Comparison of Limited-Undermining Lipoabdominoplasty and Traditional Abdominoplasty Using Laser Fluorescence Imaging. Aesthet Surg J. 2014 Jul;34(5):741-7. doi: 10.1177/1090820X14532286. Epub 2014 Jul 1.
PMID: 24809360
responsible party type: Principal Investigator
investigator affiliation: Swanson Center
investigator full name: Eric Swanson, M.D.
investigator title: Principal Investigator