<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/NCT02201979</url>
  </required_header>
  <id_info>
    <org_study_id>Swanson 004</org_study_id>
    <nct_id>NCT02201979</nct_id>
  </id_info>
  <brief_title>Laser Fluorescent Imaging of Nipple and Areola During Breast Lift</brief_title>
  <official_title>Laser Fluorescent Imaging of Nipple and Areola During Breast Lift in Combination With Breast Implants</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>
      Breast lift surgery performed in combination with breast implants is a common cosmetic&#xD;
      operation. However, there have been concerns regarding the safety of this treatment&#xD;
      combination. Some investigators are concerned that an implant may increase the risk of&#xD;
      complications, including loss of circulation to the nipple and areola. This study was&#xD;
      undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent&#xD;
      imaging and to determine whether a breast implant compromises blood supply to the nipple and&#xD;
      areola.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol&#xD;
&#xD;
      Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in&#xD;
      Combination with Breast Implants.&#xD;
&#xD;
      Background/Purpose&#xD;
&#xD;
      Today, breast lifts are a common operation. Implants may be recommended to provide greater&#xD;
      fullness of the upper poles of the breasts. One of the risks of surgery is compromised&#xD;
      circulation to the nipples and areolae. Some investigators believe that the simultaneous&#xD;
      insertion of breast implants adds to the risk by causing pressure on the overlying breast&#xD;
      tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice&#xD;
      versa) has been recommended, but staging is inconvenient and costly for patients,&#xD;
      necessitating two operations. Clinical experience with the newer vertical breast lift&#xD;
      technique, as opposed to the traditional inferior pedicle technique, has been favorable, with&#xD;
      few reported complications.2 The vertical technique uses a shorter, more superficial pedicle&#xD;
      than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and&#xD;
      reduction are essentially the same operation; more breast tissue is removed during a&#xD;
      reduction but the dissection is the same.&#xD;
&#xD;
      This study was undertaken to investigate the blood supply to the nipples and areolae during&#xD;
      the combined breast lift/reduction and implants procedure. Laser fluorescent imaging&#xD;
      represents an objective measurement technique that has been used for several years to monitor&#xD;
      the vascularity of flaps used in breast reconstruction.&#xD;
&#xD;
      Subjects&#xD;
&#xD;
      Fifteen consecutive consenting adult women undergoing outpatient elective breast lifts or&#xD;
      reductions in combination with breast implants will be investigated. By testing the blood&#xD;
      supply at two time points, the patient serves as 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 800-810 nm. The imaging agent is injected intravenously. Starting&#xD;
      within 5-10 seconds of injection, the system records images of the breasts, showing the&#xD;
      fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3&#xD;
      minutes.&#xD;
&#xD;
      Surgery&#xD;
&#xD;
      The implants are inserted and the breast lift/reduction procedure is performed on both sides&#xD;
      using the vertical technique.2 The implants are not inflated. The filling tubes are left in&#xD;
      place. At this point, 3 mL (7.5 mg) of indocyanine green is injected and the image is&#xD;
      recorded, documenting blood supply to both breasts. Next, the implants are inflated using the&#xD;
      filling tubes. After inflation of the implants, the breasts are reimaged, with the filling&#xD;
      tubes still in place. Once adequate circulation is demonstrated, the filling tubes are&#xD;
      removed. In the unlikely event that inadequate circulation is found during imaging, the&#xD;
      implant volume may be reduced accordingly, and a third image taken to confirm adequate&#xD;
      circulation to the nipples.&#xD;
&#xD;
      Null Hypothesis&#xD;
&#xD;
      A breast lift or reduction performed using the vertical technique in combination with&#xD;
      insertion of breast implants does not compromise circulation to the nipples and areolae and&#xD;
      may be safely performed simultaneously, avoiding a need for staged surgery.&#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 implant volume, or forego&#xD;
      their simultaneous insertion if necessary and reduce the risk of tissue loss and delayed&#xD;
      wound healing, known complications of breast lifts and reductions.&#xD;
&#xD;
      Sample Size&#xD;
&#xD;
      A sample of 15 patients is anticipated, treated over a period of approximately 5 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</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>
  <primary_outcome>
    <measure>Blood supply to breast as evaluated by laser fluorescent imaging</measure>
    <time_frame>5 months</time_frame>
    <description>Laser fluorescent imaging is used to evaluate breast blood supply.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Breast Sagging</condition>
  <condition>Ptosis</condition>
  <condition>Loss of Breast Volume</condition>
  <arm_group>
    <arm_group_label>Breast lift in combination with implants.</arm_group_label>
    <description>Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vertical breast lift with implants</intervention_name>
    <arm_group_label>Breast lift in combination with implants.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult women undergoing cosmetic breast lifts in combination with implants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 - 80&#xD;
&#xD;
          -  Consent for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of allergy to iodinated contrast dye -&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.</citation>
    <PMID>23806952</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 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>breast</keyword>
  <keyword>ptosis</keyword>
  <keyword>sagging</keyword>
  <keyword>implant</keyword>
  <keyword>lift</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT02201979
org study id: Swanson 004
nct id: NCT02201979
lead sponsor: 
has dmc: No
Breast lift surgery performed in combination with breast implants is a common cosmetic
      operation. However, there have been concerns regarding the safety of this treatment
      combination. Some investigators are concerned that an implant may increase the risk of
      complications, including loss of circulation to the nipple and areola. This study was
      undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent
      imaging and to determine whether a breast implant compromises blood supply to the nipple and
      areola.
Protocol

      Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in
      Combination with Breast Implants.

      Background/Purpose

      Today, breast lifts are a common operation. Implants may be recommended to provide greater
      fullness of the upper poles of the breasts. One of the risks of surgery is compromised
      circulation to the nipples and areolae. Some investigators believe that the simultaneous
      insertion of breast implants adds to the risk by causing pressure on the overlying breast
      tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice
      versa) has been recommended, but staging is inconvenient and costly for patients,
      necessitating two operations. Clinical experience with the newer vertical breast lift
      technique, as opposed to the traditional inferior pedicle technique, has been favorable, with
      few reported complications.2 The vertical technique uses a shorter, more superficial pedicle
      than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and
      reduction are essentially the same operation; more breast tissue is removed during a
      reduction but the dissection is the same.

      This study was undertaken to investigate the blood supply to the nipples and areolae during
      the combined breast lift/reduction and implants procedure. Laser fluorescent imaging
      represents an objective measurement technique that has been used for several years to monitor
      the vascularity of flaps used in breast reconstruction.

      Subjects

      Fifteen consecutive consenting adult women undergoing outpatient elective breast lifts or
      reductions in combination with breast implants will be investigated. By testing the blood
      supply at two time points, the patient serves as 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 800-810 nm. The imaging agent is injected intravenously. Starting
      within 5-10 seconds of injection, the system records images of the breasts, showing the
      fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3
      minutes.

      Surgery

      The implants are inserted and the breast lift/reduction procedure is performed on both sides
      using the vertical technique.2 The implants are not inflated. The filling tubes are left in
      place. At this point, 3 mL (7.5 mg) of indocyanine green is injected and the image is
      recorded, documenting blood supply to both breasts. Next, the implants are inflated using the
      filling tubes. After inflation of the implants, the breasts are reimaged, with the filling
      tubes still in place. Once adequate circulation is demonstrated, the filling tubes are
      removed. In the unlikely event that inadequate circulation is found during imaging, the
      implant volume may be reduced accordingly, and a third image taken to confirm adequate
      circulation to the nipples.

      Null Hypothesis

      A breast lift or reduction performed using the vertical technique in combination with
      insertion of breast implants does not compromise circulation to the nipples and areolae and
      may be safely performed simultaneously, avoiding a need for staged surgery.

      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 implant volume, or forego
      their simultaneous insertion if necessary and reduce the risk of tissue loss and delayed
      wound healing, known complications of breast lifts and reductions.

      Sample Size

      A sample of 15 patients is anticipated, treated over a period of approximately 5 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: Blood supply to breast as evaluated by laser fluorescent imaging
time frame: 5 months
description: Laser fluorescent imaging is used to evaluate breast blood supply.
arm group label: Breast lift in combination with implants.
description: Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply.
intervention type: Procedure
intervention name: Vertical breast lift with implants
arm group label: Breast lift in combination with implants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
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: Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.
PMID: 23806952
responsible party type: Principal Investigator
investigator affiliation: Swanson Center
investigator full name: Eric Swanson, M.D.
investigator title: Principal Investigator
mesh term: Prolapse