xml: <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/NCT05975359</url>
    </required_header>
    <id_info>
      <org_study_id>69609</org_study_id>
      <nct_id>NCT05975359</nct_id>
    </id_info>
    <brief_title>Assessment of the Interi Manifold in Implant-Based Breast Reconstruction</brief_title>
    <official_title>A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>IC Surgical</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR)&#xD;
        often require the placement of a surgical drain. Surgical drains are used to manage dead&#xD;
        space and prevent seroma formation or accumulation of fluid within the surgical field&#xD;
        postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is&#xD;
        limited by poor surgical site coverage and low capacity, leading to inconsistent suction and&#xD;
        prolonged time that a drain is left in place. The Interi Drain system is a novel,&#xD;
        multi-branched manifold with a proprietary suction system that provides consistent suction&#xD;
        and addresses many of the shortcoming of JP drains. The purpose of this study is to compare&#xD;
        the Interi system to standard JP drains across outcomes including number of surgical drain&#xD;
        sites, complication rates, time to drain removal, time to initiate tissue expansion, total&#xD;
        fluid volume drained, and patient satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients seeking a mastectomy with immediate tissue expander/implant-based breast&#xD;
        reconstruction will be considered. Potential participants will be screened for inclusion and&#xD;
        exclusion criteria and informed of the study protocols, risk, and potential benefits.&#xD;
  &#xD;
        Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and&#xD;
        immediate, implant-based breast reconstruction using a tissue expander. On the day of&#xD;
        surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such&#xD;
        that in each patient one breast receives the Interi drain and the other receives JP drains.&#xD;
        Randomization will be stratified by the laterality of the primary tumor. The respective&#xD;
        drains will be placed intraoperatively.&#xD;
  &#xD;
        Postoperative care will proceed as standard. Postoperative follow-up will occur within 1 week&#xD;
        of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will&#xD;
        also take place until removal of the drain systems, which typically occurs 1-3 weeks after&#xD;
        surgery. While drains are in place, patients will be required to monitor drain output and&#xD;
        keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly)&#xD;
        according to the usual clinical practice of implant-based breast reconstruction. This will&#xD;
        include routine tissue expansion in preparation for the second stage expander to definitive&#xD;
        implant exchange.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device safety</measure>
      <time_frame>Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.</time_frame>
      <description>Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to drain removal</measure>
      <time_frame>Drain removal typically occurs between 1-3 weeks post-op.</time_frame>
      <description>The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of drain sites</measure>
      <time_frame>This will be recorded by the surgeon immediately after completion of the stage 1 operation.</time_frame>
      <description>The number of drain sites (holes exiting the surgical site) in each breast.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total fluid drained</measure>
      <time_frame>Drain removal typically occurs between 1-3 weeks post-op.</time_frame>
      <description>The amount of fluid (mL) collected by each surgical drain from the operative breast for the duration of drain placement will be recorded for both drain systems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to initiate tissue expansion</measure>
      <time_frame>Tissue expansion typically begins 3-6 weeks after stage 1 surgery.</time_frame>
      <description>The amount of time in days after tissue expander placement (same operative time point as drain placement) for a patient to begin tissue expansion (when determined clinically appropriate by the attending physician).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction (BreastQ)</measure>
      <time_frame>Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).</time_frame>
      <description>Both quality of life and patient satisfaction will be assessed by validated patient survey (BreastQ). Each breast will be assessed independently by the patient to determine if the type of drain has affected the patient's perception of their recovery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction (study-specific survey)</measure>
      <time_frame>Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).</time_frame>
      <description>Patient satisfaction with each drain system and ease of use will be assessed using a study-specific survey.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Mastectomy</condition>
    <condition>Implant Based Breast Reconstruction</condition>
    <arm_group>
      <arm_group_label>Interi Manifold Drain System</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Interi manifold (intervention arm) will have the Interi manifold placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Interi drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Jackson Pratt Drain System</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Jackson Pratt drain (active comparator arm) will have the Jackson Pratt drain placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Jackson Pratt drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Interi Manifold Drain System</intervention_name>
      <description>The Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff.</description>
      <arm_group_label>Interi Manifold Drain System</arm_group_label>
      <other_name>Interi manifold; Interi drain; Interi surgical drain</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Jackson Pratt Drain System</intervention_name>
      <description>The Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff.</description>
      <arm_group_label>Jackson Pratt Drain System</arm_group_label>
      <other_name>JP drain; JP surgical drain</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients ages 18 - 65 with a breast cancer diagnosis or other indication for&#xD;
               bilateral mastectomy, who plan to undergo immediate implant-based pre-pectoral breast&#xD;
               reconstruction, and who are willing and able to understand the informed consent&#xD;
               document may be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of radiation to the breast or who have planned radiotherapy to&#xD;
               the breast within the first year post-operatively; have ECOG status &gt; 2; are enrolled&#xD;
               in another study that requires the concomitant use of any investigational product&#xD;
               during the study period; have received chemotherapy within the past 21 days or have&#xD;
               chemotherapy planned within the time fame of the study intervention (while drains are&#xD;
               in place); have received anti-platelet therapy (other than aspirin) and/ or other&#xD;
               anticoagulation therapy in the past 60 days; are a smoker or use illicit drugs; have a&#xD;
               prior history of allergic reaction to teflon; are pregnant or nursing; plan to undergo&#xD;
               a delayed reconstruction after mastectomy; have an HIV infection, active UTI or other&#xD;
               infection; or those requiring more than one Interi manifold for fluid removal per&#xD;
               breast will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dung H Nguyen, MD, PharmD</last_name>
      <phone>(650) 725-2766</phone>
      <email>nguyendh@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shannon Meyer, CCRC</last_name>
      <phone>510-418-3831</phone>
      <email>smeyer27@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford Hospital and Clinics</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Dung Nguyen</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975359
  org study id: 69609
  nct id: NCT05975359
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR)
        often require the placement of a surgical drain. Surgical drains are used to manage dead
        space and prevent seroma formation or accumulation of fluid within the surgical field
        postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is
        limited by poor surgical site coverage and low capacity, leading to inconsistent suction and
        prolonged time that a drain is left in place. The Interi Drain system is a novel,
        multi-branched manifold with a proprietary suction system that provides consistent suction
        and addresses many of the shortcoming of JP drains. The purpose of this study is to compare
        the Interi system to standard JP drains across outcomes including number of surgical drain
        sites, complication rates, time to drain removal, time to initiate tissue expansion, total
        fluid volume drained, and patient satisfaction.
  Patients seeking a mastectomy with immediate tissue expander/implant-based breast
        reconstruction will be considered. Potential participants will be screened for inclusion and
        exclusion criteria and informed of the study protocols, risk, and potential benefits.
  
        Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and
        immediate, implant-based breast reconstruction using a tissue expander. On the day of
        surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such
        that in each patient one breast receives the Interi drain and the other receives JP drains.
        Randomization will be stratified by the laterality of the primary tumor. The respective
        drains will be placed intraoperatively.
  
        Postoperative care will proceed as standard. Postoperative follow-up will occur within 1 week
        of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will
        also take place until removal of the drain systems, which typically occurs 1-3 weeks after
        surgery. While drains are in place, patients will be required to monitor drain output and
        keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly)
        according to the usual clinical practice of implant-based breast reconstruction. This will
        include routine tissue expansion in preparation for the second stage expander to definitive
        implant exchange.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Device safety
  time frame: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
  description: Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
  measure: Time to drain removal
  time frame: Drain removal typically occurs between 1-3 weeks post-op.
  description: The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL).
  measure: Number of drain sites
  time frame: This will be recorded by the surgeon immediately after completion of the stage 1 operation.
  description: The number of drain sites (holes exiting the surgical site) in each breast.
  measure: Total fluid drained
  time frame: Drain removal typically occurs between 1-3 weeks post-op.
  description: The amount of fluid (mL) collected by each surgical drain from the operative breast for the duration of drain placement will be recorded for both drain systems.
  measure: Time to initiate tissue expansion
  time frame: Tissue expansion typically begins 3-6 weeks after stage 1 surgery.
  description: The amount of time in days after tissue expander placement (same operative time point as drain placement) for a patient to begin tissue expansion (when determined clinically appropriate by the attending physician).
  measure: Patient satisfaction (BreastQ)
  time frame: Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
  description: Both quality of life and patient satisfaction will be assessed by validated patient survey (BreastQ). Each breast will be assessed independently by the patient to determine if the type of drain has affected the patient's perception of their recovery.
  measure: Patient satisfaction (study-specific survey)
  time frame: Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).
  description: Patient satisfaction with each drain system and ease of use will be assessed using a study-specific survey.
  arm group label: Interi Manifold Drain System
  arm group type: Experimental
  description: Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Interi manifold (intervention arm) will have the Interi manifold placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Interi drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.
  arm group label: Jackson Pratt Drain System
  arm group type: Active Comparator
  description: Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Jackson Pratt drain (active comparator arm) will have the Jackson Pratt drain placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Jackson Pratt drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log.
  intervention type: Device
  intervention name: Interi Manifold Drain System
  description: The Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff.
  arm group label: Interi Manifold Drain System
  other name: Interi manifold; Interi drain; Interi surgical drain
  intervention type: Device
  intervention name: Jackson Pratt Drain System
  description: The Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff.
  arm group label: Jackson Pratt Drain System
  other name: JP drain; JP surgical drain
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Dung H Nguyen, MD, PharmD
  phone: (650) 725-2766
  email: nguyendh@stanford.edu
  last name: Shannon Meyer, CCRC
  phone: 510-418-3831
  email: smeyer27@stanford.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Dung Nguyen
  investigator title: Clinical Professor
  sharing ipd: No