<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/NCT03764943</url>
  </required_header>
  <id_info>
    <org_study_id>UW18101</org_study_id>
    <secondary_id>2018-1107</secondary_id>
    <secondary_id>A539730</secondary_id>
    <secondary_id>SMPH/SURGERY/DENTL-PLASTC SRGY</secondary_id>
    <secondary_id>Protocol version 5/8/2020</secondary_id>
    <secondary_id>NCI-2018-02896</secondary_id>
    <nct_id>NCT03764943</nct_id>
  </id_info>
  <brief_title>Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction</brief_title>
  <official_title>Evaluating the Use of Enhanced Recovery Preoperative Immunonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to test the following hypothesis: patients undergoing immediate&#xD;
      alloplastic and autologous breast reconstruction following mastectomy that receive&#xD;
      preoperative immunonutrition will experience a reduction in wound complications in the 30-day&#xD;
      postoperative period compared to a standard of care control group (retrospective chart&#xD;
      review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients&#xD;
      prior to 5/25/2018.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast reconstruction following mastectomy for breast cancer is one of the most common&#xD;
      operations performed by plastic and reconstructive surgeons. Unfortunately, breast&#xD;
      reconstruction does not come without complications. Both alloplastic and autologous forms of&#xD;
      reconstruction are frequently complicated by wound healing and infectious complications.&#xD;
      These complications range from incisional dehiscence requiring prolonged wound care and daily&#xD;
      dressing changes, to expander infection and extrusion requiring operative removal, to&#xD;
      mastectomy skin flap necrosis so severe that operative debridement is required during a&#xD;
      second surgery after declaration of viable skin has occurred.&#xD;
&#xD;
      This study is designed to test the hypothesis that patients undergoing immediate alloplastic&#xD;
      and autologous breast reconstruction following mastectomy that receive preoperative&#xD;
      immunonutrition will experience a reduction in wound complications in the 30-day&#xD;
      postoperative period compared to a standard of care control group (retrospective chart&#xD;
      review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients&#xD;
      prior to 5/25/2018.&#xD;
&#xD;
      The overarching goal of perioperative immunonutrition supplementation is to offset the immune&#xD;
      and metabolic dysregulation that occurs in response to surgical stress. The key ingredients&#xD;
      that promote this response are amino acids (typically arginine), fatty acids and nucleotides;&#xD;
      these can be administered individually but are typically administered together in an enteral&#xD;
      or parenteral formula.&#xD;
&#xD;
      The primary outcome measure of the protocol is the incidence of wound complications 30-days&#xD;
      post-operative.&#xD;
&#xD;
      Secondary outcome measures are:&#xD;
&#xD;
        1. Rate of return to the operating room in the 30-day postoperative period in patients&#xD;
           undergoing immediate alloplastic and autologous breast reconstruction.&#xD;
&#xD;
        2. Average length of stay for patients undergoing autologous reconstruction.&#xD;
&#xD;
        3. Incidence of wound complications and return to the operating room 90-days post-operative&#xD;
           throughout expansion process for patients undergoing alloplastic reconstruction.&#xD;
&#xD;
      The study duration will be approximately 33 weeks assuming 100% compliance with the treatment&#xD;
      arms in the alloplastic and autologous populations. The time estimate is based on recent&#xD;
      trends in operative schedules of 2 immediate alloplastic and 2 immediate autologous breast&#xD;
      reconstruction operations weekly with a calculated sample size of 66 patients in each group&#xD;
      (total n=132). This sample size was calculated assuming significance level of 0.05, power of&#xD;
      80%, and 50% reduction in wound complications in the treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</primary_completion_date>
  <phase>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>
    <intervention_model_description>Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Incidents of Wound Complications 30-days Post-Op</measure>
    <time_frame>up to 30 days post-op</time_frame>
    <description>Wound complications are defined by the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to include surgical site infection (SSI), deep SSI, organ/space SSI, wound disruption/dehiscence, seroma, and skin necrosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients that Return to the Operating Room 30-days Post-Op</measure>
    <time_frame>up to 30 days post-op</time_frame>
    <description>The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients that require additional surgery due to wound complications 30-days Post-Op, compared to a retrospective standard of care control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Length of Hospitalization for Autologous Reconstruction Patients</measure>
    <time_frame>up to 1 weeks</time_frame>
    <description>The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying average length of hospitalization for Autologous Reconstruction patients, compared to a retrospective standard of care control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Wound Complications for Alloplastic Reconstruction Patients up to 90-days Post-Op</measure>
    <time_frame>up to 90 days post-op</time_frame>
    <description>Wound complications are defined by the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to include surgical site infection (SSI), deep SSI, organ/space SSI, wound disruption/dehiscence, seroma, and skin necrosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Alloplastic Reconstruction Patients that Return to the Operating Room up to 90-days Post-Op</measure>
    <time_frame>up to 90 days post-op</time_frame>
    <description>The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients undergoing Alloplastic Reconstruction that require additional surgery due to wound complications 90-days Post-Op, compared to a retrospective standard of care control group.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Wound Complication</condition>
  <condition>Wound Heal</condition>
  <condition>Complications Wound</condition>
  <condition>Surgical Wound Infection</condition>
  <condition>Surgical Site Infection</condition>
  <condition>Breast Cancer</condition>
  <condition>Mastectomy; Lymphedema</condition>
  <arm_group>
    <arm_group_label>Immunonutrition Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume 3 'Impact Advanced Recovery' shakes daily for 5 days prior to surgery 2 hours prior to surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Impact Advanced Recovery</intervention_name>
    <description>immunonutrition shake; nutritional supplement containing amino acids, omega-3 fatty acids, and nucleotides</description>
    <arm_group_label>Immunonutrition Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically cleared to undergo oncologic resection and breast reconstructive surgery&#xD;
             (including associated anesthesia) at the University of Wisconsin Hospital&#xD;
&#xD;
          -  Undergoing unilateral or bilateral immediate alloplastic or autologous breast&#xD;
             reconstruction by Drs. Afifi, Garland, Gast, Michelotti, Poore, Rao, or Siebert&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Incarcerated women&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Individuals unable to give consent due to another condition such as impaired&#xD;
             decision-making capacity&#xD;
&#xD;
          -  Women with intolerance or allergy to any ingredients contained within the Impact&#xD;
             Advanced Recovery formula that prevents safe consumption of this product.&#xD;
&#xD;
               -  Impact Advanced Recovery is suitable for lactose intolerance, gluten-free,&#xD;
                  kosher, and halal diets.&#xD;
&#xD;
               -  We will exclude individuals with galactosemia&#xD;
&#xD;
          -  Women who are unable to take oral nutritional supplements&#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>Katherine Gast, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03764943
org study id: UW18101
secondary id: 2018-1107
secondary id: A539730
secondary id: SMPH/SURGERY/DENTL-PLASTC SRGY
secondary id: Protocol version 5/8/2020
secondary id: NCI-2018-02896
nct id: NCT03764943
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed to test the following hypothesis: patients undergoing immediate
      alloplastic and autologous breast reconstruction following mastectomy that receive
      preoperative immunonutrition will experience a reduction in wound complications in the 30-day
      postoperative period compared to a standard of care control group (retrospective chart
      review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients
      prior to 5/25/2018.
Breast reconstruction following mastectomy for breast cancer is one of the most common
      operations performed by plastic and reconstructive surgeons. Unfortunately, breast
      reconstruction does not come without complications. Both alloplastic and autologous forms of
      reconstruction are frequently complicated by wound healing and infectious complications.
      These complications range from incisional dehiscence requiring prolonged wound care and daily
      dressing changes, to expander infection and extrusion requiring operative removal, to
      mastectomy skin flap necrosis so severe that operative debridement is required during a
      second surgery after declaration of viable skin has occurred.

      This study is designed to test the hypothesis that patients undergoing immediate alloplastic
      and autologous breast reconstruction following mastectomy that receive preoperative
      immunonutrition will experience a reduction in wound complications in the 30-day
      postoperative period compared to a standard of care control group (retrospective chart
      review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients
      prior to 5/25/2018.

      The overarching goal of perioperative immunonutrition supplementation is to offset the immune
      and metabolic dysregulation that occurs in response to surgical stress. The key ingredients
      that promote this response are amino acids (typically arginine), fatty acids and nucleotides;
      these can be administered individually but are typically administered together in an enteral
      or parenteral formula.

      The primary outcome measure of the protocol is the incidence of wound complications 30-days
      post-operative.

      Secondary outcome measures are:

        1. Rate of return to the operating room in the 30-day postoperative period in patients
           undergoing immediate alloplastic and autologous breast reconstruction.

        2. Average length of stay for patients undergoing autologous reconstruction.

        3. Incidence of wound complications and return to the operating room 90-days post-operative
           throughout expansion process for patients undergoing alloplastic reconstruction.

      The study duration will be approximately 33 weeks assuming 100% compliance with the treatment
      arms in the alloplastic and autologous populations. The time estimate is based on recent
      trends in operative schedules of 2 immediate alloplastic and 2 immediate autologous breast
      reconstruction operations weekly with a calculated sample size of 66 patients in each group
      (total n=132). This sample size was calculated assuming significance level of 0.05, power of
      80%, and 50% reduction in wound complications in the treatment group.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Incidents of Wound Complications 30-days Post-Op
time frame: up to 30 days post-op
description: Wound complications are defined by the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to include surgical site infection (SSI), deep SSI, organ/space SSI, wound disruption/dehiscence, seroma, and skin necrosis.
measure: Number of Patients that Return to the Operating Room 30-days Post-Op
time frame: up to 30 days post-op
description: The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients that require additional surgery due to wound complications 30-days Post-Op, compared to a retrospective standard of care control group.
measure: Average Length of Hospitalization for Autologous Reconstruction Patients
time frame: up to 1 weeks
description: The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying average length of hospitalization for Autologous Reconstruction patients, compared to a retrospective standard of care control group.
measure: Rate of Wound Complications for Alloplastic Reconstruction Patients up to 90-days Post-Op
time frame: up to 90 days post-op
description: Wound complications are defined by the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to include surgical site infection (SSI), deep SSI, organ/space SSI, wound disruption/dehiscence, seroma, and skin necrosis.
measure: Number of Alloplastic Reconstruction Patients that Return to the Operating Room up to 90-days Post-Op
time frame: up to 90 days post-op
description: The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients undergoing Alloplastic Reconstruction that require additional surgery due to wound complications 90-days Post-Op, compared to a retrospective standard of care control group.
arm group label: Immunonutrition Intervention
arm group type: Experimental
description: Participants will consume 3 'Impact Advanced Recovery' shakes daily for 5 days prior to surgery 2 hours prior to surgery.
intervention type: Dietary Supplement
intervention name: Impact Advanced Recovery
description: immunonutrition shake; nutritional supplement containing amino acids, omega-3 fatty acids, and nucleotides
arm group label: Immunonutrition Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Gast, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Wound Infection
mesh term: Lymphedema
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No