<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/NCT03757793</url>
  </required_header>
  <id_info>
    <org_study_id>18/12/173</org_study_id>
    <nct_id>NCT03757793</nct_id>
  </id_info>
  <brief_title>Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction</brief_title>
  <official_title>Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early&#xD;
      microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a complex resection for breast cancer (e.g. mastectomy), a microvascular flap&#xD;
      reconstruction can be used to fill up the tissue defects. A deep inferior epigastric artery&#xD;
      perforator (DIEP)-flap is one of the most used microvascular flap reconstructions. Skin and&#xD;
      fat from the abdomen are used to reconstruct a new breast.The success ratio of this type of&#xD;
      surgery is high, more than 95%. Nevertheless, free flap failure can have disastrous&#xD;
      consequences.The flap can be injured by surgical factors such as vascular complications.This&#xD;
      is one of the major concerns and it usually occurs in the first hours after surgery. The&#xD;
      success rate of the free flap depends on the continuous arterial inflow and the venous&#xD;
      outflow through the new microvascular anastomoses. Thrombosis, kinking or external&#xD;
      compression on the micro- and macrovascular blood vessels can cause necrosis of the flap. It&#xD;
      is essential to recognize these complications as fast as possible to maximize the potential&#xD;
      for flap salvage. Physical examination is still the gold standard for flap monitoring.&#xD;
      However this monitoring is subjective, labor intensive and requires experience. Because of&#xD;
      these disadvantages, a more objective method is desirable. In this suggested project, the&#xD;
      flap will be monitored with FORE-SIGHT ELITE monitor( CAS Medical Systems incorporated)&#xD;
      during the first 12 hours postoperatively. In this period most complications occur. The&#xD;
      FORE-SIGHT ELITE Absolute Tissue Oximeter is a non-invasive device that measures absolute&#xD;
      tissue oxygen saturation. It operates on the principle that blood contains hemoglobin in two&#xD;
      primary forms, oxygenated hemoglobin (HbO2 ) and de-oxygenated hemoglobin (Hb), which absorb&#xD;
      near-infrared light in different, measurable ways.The FORE-SIGHT ELITE incorporates CAS&#xD;
      Medical Systems exclusive technology to project harmless near-infrared light in five precise&#xD;
      wavelengths (690, 730, 770, 810 and 870 nanometer). An algorithm analyzes the reflected&#xD;
      wavelengths. The algorithm is specially designed for the tissue with attention to unique&#xD;
      characteristics of the tissue. Reflected light is captured by detectors positioned on the&#xD;
      sensor for optimal signal collection. After analyzing the reflected light, the FORE-SIGHT&#xD;
      ELITE displays the tissue oxygen saturation level on the monitor as an absolute number and&#xD;
      provides a graphical representation of historical values.The FORE-SIGHT ELITE has been&#xD;
      validated to determine cerebral tissue oxygen saturation amongst other in brain surgery.&#xD;
      Tissue oxygen saturation (StO2) levels are determined by the ratio of oxygenated hemoglobin&#xD;
      to total hemoglobin at the microvascular level (arterioles, venules, and capillaries) in the&#xD;
      region to which the sensor is applied. This technique is called Near Infrared Spectroscopy&#xD;
      (NIRS).Validated use of NIRS would be a major advantage to detect ischaemia in DIEP flaps. In&#xD;
      the study pediatric sensor size is used to ensure proper depth of light penetration in a&#xD;
      limited operating zone. By application of small neonatal sensors ( Foresight®-sensors&#xD;
      (CASMED, Branford, CT, USA), on unilateral or bilateral DIEP flaps,light penetrates at 1.25cm&#xD;
      depth.This reflects the perfusion and the oxygen consumption in the free flap.&#xD;
&#xD;
      A control pediatric sensor is placed on the abdomen where tissue is taken to perform the DIEP&#xD;
      flap. This sensor reflects the normal tissue oxygenation of the patient. NIRS uses this&#xD;
      technology for the detection of ischemia and hypoxia. It is a real-time, continuous,&#xD;
      non-invasive method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 28, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of ischaemia after DIEP flap surgery by use of NIRS</measure>
    <time_frame>first 12 hours post surgery</time_frame>
    <description>The aim of the study is to determine whether near infrared spectrometry(NIRS) would be a validated tool to detect early microvascular complications. A decrease of 10% of the Sct O2 taken at the DIEP flap(s) compared to Sct O2 of the abdomen will be considered as possible risk of ischaemia.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Mastectomy</condition>
  <condition>Breast Reconstruction</condition>
  <condition>Flap Ischemia</condition>
  <arm_group>
    <arm_group_label>Reliability of NIRS in DIEP flap surgery</arm_group_label>
    <description>In patients who underwent DIEP flap surgery, monitoring of postoperative tissue oxygen saturation of the flap by use of the FORE-SIGHT Elite monitor will be compared to standard of care physical examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FORE-SIGHT ELITE monitor</intervention_name>
    <description>At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.</description>
    <arm_group_label>Reliability of NIRS in DIEP flap surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women, over 18 years, undergoing unilateral or bilateral DIEP flap procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of written informed consent&#xD;
&#xD;
          -  redo-surgery&#xD;
&#xD;
          -  known history of allergy to adhesives&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vera Saldien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vera Saldien, MD</last_name>
    <phone>38214788</phone>
    <phone_ext>0032</phone_ext>
    <email>vera.saldien@uza.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joke De Wachter</last_name>
    <phone>38213042</phone>
    <phone_ext>0032</phone_ext>
    <email>joke.dewachter@uza.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vera Saldien, MD</last_name>
      <phone>38214788</phone>
      <phone_ext>0032</phone_ext>
      <email>vera.saldien@uza.be</email>
    </contact>
    <contact_backup>
      <last_name>Joke De Wachter</last_name>
      <phone>38213042</phone>
      <phone_ext>0032</phone_ext>
      <email>joke.dewachter@uza.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Joke De Wachter</investigator_full_name>
    <investigator_title>data manager</investigator_title>
  </responsible_party>
  <keyword>Near infrared spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</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/NCT03757793
org study id: 18/12/173
nct id: NCT03757793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early
      microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).
After a complex resection for breast cancer (e.g. mastectomy), a microvascular flap
      reconstruction can be used to fill up the tissue defects. A deep inferior epigastric artery
      perforator (DIEP)-flap is one of the most used microvascular flap reconstructions. Skin and
      fat from the abdomen are used to reconstruct a new breast.The success ratio of this type of
      surgery is high, more than 95%. Nevertheless, free flap failure can have disastrous
      consequences.The flap can be injured by surgical factors such as vascular complications.This
      is one of the major concerns and it usually occurs in the first hours after surgery. The
      success rate of the free flap depends on the continuous arterial inflow and the venous
      outflow through the new microvascular anastomoses. Thrombosis, kinking or external
      compression on the micro- and macrovascular blood vessels can cause necrosis of the flap. It
      is essential to recognize these complications as fast as possible to maximize the potential
      for flap salvage. Physical examination is still the gold standard for flap monitoring.
      However this monitoring is subjective, labor intensive and requires experience. Because of
      these disadvantages, a more objective method is desirable. In this suggested project, the
      flap will be monitored with FORE-SIGHT ELITE monitor( CAS Medical Systems incorporated)
      during the first 12 hours postoperatively. In this period most complications occur. The
      FORE-SIGHT ELITE Absolute Tissue Oximeter is a non-invasive device that measures absolute
      tissue oxygen saturation. It operates on the principle that blood contains hemoglobin in two
      primary forms, oxygenated hemoglobin (HbO2 ) and de-oxygenated hemoglobin (Hb), which absorb
      near-infrared light in different, measurable ways.The FORE-SIGHT ELITE incorporates CAS
      Medical Systems exclusive technology to project harmless near-infrared light in five precise
      wavelengths (690, 730, 770, 810 and 870 nanometer). An algorithm analyzes the reflected
      wavelengths. The algorithm is specially designed for the tissue with attention to unique
      characteristics of the tissue. Reflected light is captured by detectors positioned on the
      sensor for optimal signal collection. After analyzing the reflected light, the FORE-SIGHT
      ELITE displays the tissue oxygen saturation level on the monitor as an absolute number and
      provides a graphical representation of historical values.The FORE-SIGHT ELITE has been
      validated to determine cerebral tissue oxygen saturation amongst other in brain surgery.
      Tissue oxygen saturation (StO2) levels are determined by the ratio of oxygenated hemoglobin
      to total hemoglobin at the microvascular level (arterioles, venules, and capillaries) in the
      region to which the sensor is applied. This technique is called Near Infrared Spectroscopy
      (NIRS).Validated use of NIRS would be a major advantage to detect ischaemia in DIEP flaps. In
      the study pediatric sensor size is used to ensure proper depth of light penetration in a
      limited operating zone. By application of small neonatal sensors ( Foresight®-sensors
      (CASMED, Branford, CT, USA), on unilateral or bilateral DIEP flaps,light penetrates at 1.25cm
      depth.This reflects the perfusion and the oxygen consumption in the free flap.

      A control pediatric sensor is placed on the abdomen where tissue is taken to perform the DIEP
      flap. This sensor reflects the normal tissue oxygenation of the patient. NIRS uses this
      technology for the detection of ischemia and hypoxia. It is a real-time, continuous,
      non-invasive method.
observational model: Cohort
time perspective: Prospective
measure: Detection of ischaemia after DIEP flap surgery by use of NIRS
time frame: first 12 hours post surgery
description: The aim of the study is to determine whether near infrared spectrometry(NIRS) would be a validated tool to detect early microvascular complications. A decrease of 10% of the Sct O2 taken at the DIEP flap(s) compared to Sct O2 of the abdomen will be considered as possible risk of ischaemia.
arm group label: Reliability of NIRS in DIEP flap surgery
description: In patients who underwent DIEP flap surgery, monitoring of postoperative tissue oxygen saturation of the flap by use of the FORE-SIGHT Elite monitor will be compared to standard of care physical examination.
intervention type: Device
intervention name: FORE-SIGHT ELITE monitor
description: At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.
arm group label: Reliability of NIRS in DIEP flap surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vera Saldien, MD
role: Principal Investigator
affiliation: University Hospital, Antwerp
last name: Vera Saldien, MD
phone: 38214788
phone ext: 0032
email: vera.saldien@uza.be
last name: Joke De Wachter
phone: 38213042
phone ext: 0032
email: joke.dewachter@uza.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Joke De Wachter
investigator title: data manager
mesh term: Ischemia