<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/NCT03784859</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00052823</org_study_id>
    <nct_id>NCT03784859</nct_id>
  </id_info>
  <brief_title>Tissue Expansion in Breast Reconstruction Without Drains</brief_title>
  <official_title>Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sientra, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this small feasibility pilot study is to demonstrate that&#xD;
      implant-based breast reconstruction (after treatment for cancer) can successfully be&#xD;
      performed without prolonged drain placement, using a tissue expander with a reservoir and&#xD;
      in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough&#xD;
      confidence in this technique that a larger study can be performed to demonstrate fewer&#xD;
      complications (infection, drain-related pain and re-operation rates) when compared to the use&#xD;
      of conventional tissue expanders and/or implants with prolonged drain placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients electing to have staged, implant-based, bilateral breast reconstruction at the time&#xD;
      of mastectomy (for either cancer or cancer prevention) will undergo a standardized&#xD;
      subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each&#xD;
      side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the&#xD;
      subcutaneous pocket of each breast will be used and removed on the first post-operative day.&#xD;
      Patients will be admitted for overnight observation in the hospital. Each post-operative day&#xD;
      fluid will be aspirated from each reservoir port using a standard sterile technique, and the&#xD;
      volume recorded. After discharge, patients will be seen in the office within one week of&#xD;
      discharge and fluid aspirated from each expander using the reservoir ports, and the volume&#xD;
      shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or&#xD;
      the amount of fluid aspirated is less than 10 cc.&#xD;
&#xD;
      Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their&#xD;
      attitudes about their breast reconstruction, first at completion of tissue expansion and&#xD;
      finally at their first follow-up visit following placement of permanent breast implants.&#xD;
&#xD;
      This study utilizes FDA 510k-classified devices that allow removal of fluid without drains,&#xD;
      in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">October 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 13, 2020</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>Number of patients with successful breast reconstruction using reservoir-expanders</measure>
    <time_frame>4-6 months</time_frame>
    <description>The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Hereditary Breast and Ovarian Cancer Syndrome</condition>
  <condition>Breast Implant; Complications</condition>
  <arm_group>
    <arm_group_label>All patients in study</arm_group_label>
    <description>5 consecutive patients with breast cancer or a breast cancer-causing gene that elect to undergo bilateral breast reconstruction will be Insertion of Tissue Expander with Fluid Reservoir as the first stage of reconstruction. Post-surgical care will be similar as patients with conventional expanders, except that during office visits, fluid will be transcutaneously aspirated from the fluid reservoir on each side.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of Tissue Expander with Fluid Reservoir</intervention_name>
    <description>Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.</description>
    <arm_group_label>All patients in study</arm_group_label>
    <other_name>Sientra AlloX2 Expander</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women over the age of 21 with breast cancer or a gene that increases the risk of breast&#xD;
        cancer who elect to undergo bilateral mastectomies and two-stage implant-based&#xD;
        reconstruction using tissue expanders and permanent implants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing bilateral breast reconstruction following mastectomy (performed to&#xD;
             treat stage I-III breast cancer or for prevention of breast cancer).&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  BMI less than 31&#xD;
&#xD;
          -  No other significant surgical risk factors that make elective use of implants&#xD;
             dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners,&#xD;
             uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unilateral mastectomy patients&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Those with bleeding dyscrasias or clotting disorders&#xD;
&#xD;
          -  Those who have had or will have a full axillary lymph node dissection&#xD;
&#xD;
          -  Cases where there is an unusually high degree of bleeding intra-operatively (more than&#xD;
             150 cc)&#xD;
&#xD;
          -  Those with a BMI greater than 30&#xD;
&#xD;
          -  Those with history of prior breast surgery (aside from lumpectomy or needle biopsy)&#xD;
&#xD;
          -  Those with a history of prior breast radiation&#xD;
&#xD;
          -  Those with stage IV or unresectable breast cancer&#xD;
&#xD;
          -  Significant surgical risk factors that make elective use of implants dangerous (e.g.,&#xD;
             presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled&#xD;
             diabetes, bleeding tendencies, autoimmune disorders, immune compromise)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female breast cancer patients are usually candidates for reconstruction using breast implants</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward C Ray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Smith JM, Broyles JM, Guo Y, Tuffaha SH, Mathes D, Sacks JM. Human acellular dermis increases surgical site infection and overall complication profile when compared with submuscular breast reconstruction: An updated meta-analysis incorporating new products✰. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556. doi: 10.1016/j.bjps.2018.06.012. Epub 2018 Jul 6.</citation>
    <PMID>30093286</PMID>
  </reference>
  <reference>
    <citation>Kim JYS, Davila AA, Persing S, Connor CM, Jovanovic B, Khan SA, Fine N, Rawlani V. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012 Jan;129(1):28-41. doi: 10.1097/PRS.0b013e3182361fd6.</citation>
    <PMID>22186498</PMID>
  </reference>
  <reference>
    <citation>Ollech CJ, Block LM, Afifi AM, Poore SO. Effect of Drain Placement on Infection, Seroma, and Return to Operating Room in Expander-Based Breast Reconstruction. Ann Plast Surg. 2017 Dec;79(6):536-540. doi: 10.1097/SAP.0000000000001174.</citation>
    <PMID>28671886</PMID>
  </reference>
  <reference>
    <citation>Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31.</citation>
    <PMID>23346164</PMID>
  </reference>
  <reference>
    <citation>Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.</citation>
    <PMID>22693384</PMID>
  </reference>
  <reference>
    <citation>Murray JD, Elwood ET, Jones GE, Barrick R, Feng J. Decreasing expander breast infection: A new drain care protocol. Can J Plast Surg. 2009 Spring;17(1):17-21.</citation>
    <PMID>20190908</PMID>
  </reference>
  <reference>
    <citation>Carcoforo P, Soliani G, Maestroni U, Donini A, Inderbitzin D, Hui TT, Lefor A, Avital I, Navarra G. Octreotide in the treatment of lymphorrhea after axillary node dissection: a prospective randomized controlled trial. J Am Coll Surg. 2003 Mar;196(3):365-9. doi: 10.1016/S1072-7515(02)01757-X.</citation>
    <PMID>12648685</PMID>
  </reference>
  <reference>
    <citation>Park JE, Nigam M, Shenaq DS, Song DH. A simple, safe technique for thorough seroma evacuation in the outpatient setting. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e212. doi: 10.1097/GOX.0000000000000179. eCollection 2014 Sep.</citation>
    <PMID>25426395</PMID>
  </reference>
  <reference>
    <citation>Puttawibul P, Sangthong B, Maipang T, Sampao S, Uttamakul P, Apakupakul N. Mastectomy without drain at pectoral area: a randomized controlled trial. J Med Assoc Thai. 2003 Apr;86(4):325-31.</citation>
    <PMID>12757076</PMID>
  </reference>
  <reference>
    <citation>Rose JF, Zafar SN, Ellsworth Iv WA. Does Acellular Dermal Matrix Thickness Affect Complication Rate in Tissue Expander Based Breast Reconstruction? Plast Surg Int. 2016;2016:2867097. doi: 10.1155/2016/2867097. Epub 2016 Apr 12.</citation>
    <PMID>27190645</PMID>
  </reference>
  <reference>
    <citation>Zeidler KR, Capizzi PJ, Pittman TA. Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):29S-39S. doi: 10.1097/PRS.0000000000004352.</citation>
    <PMID>29595716</PMID>
  </reference>
  <reference>
    <citation>Moyer KE, Potochny JD. Technique for seroma drainage in implant-based breast reconstruction. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1614-7. doi: 10.1016/j.bjps.2012.06.016. Epub 2012 Jul 6.</citation>
    <PMID>22770571</PMID>
  </reference>
  <reference>
    <citation>Jordan SW, Khavanin N, Kim JYS. Seroma in Prosthetic Breast Reconstruction. Plast Reconstr Surg. 2016 Apr;137(4):1104-1116. doi: 10.1097/01.prs.0000481102.24444.72.</citation>
    <PMID>27018665</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 2, 2020</last_update_submitted>
  <last_update_submitted_qc>October 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Edward Ray</investigator_full_name>
    <investigator_title>Staff Physician II</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hereditary Breast and Ovarian Cancer Syndrome</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/NCT03784859
org study id: Pro00052823
nct id: NCT03784859
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of this small feasibility pilot study is to demonstrate that
      implant-based breast reconstruction (after treatment for cancer) can successfully be
      performed without prolonged drain placement, using a tissue expander with a reservoir and
      in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough
      confidence in this technique that a larger study can be performed to demonstrate fewer
      complications (infection, drain-related pain and re-operation rates) when compared to the use
      of conventional tissue expanders and/or implants with prolonged drain placement.
Patients electing to have staged, implant-based, bilateral breast reconstruction at the time
      of mastectomy (for either cancer or cancer prevention) will undergo a standardized
      subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each
      side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the
      subcutaneous pocket of each breast will be used and removed on the first post-operative day.
      Patients will be admitted for overnight observation in the hospital. Each post-operative day
      fluid will be aspirated from each reservoir port using a standard sterile technique, and the
      volume recorded. After discharge, patients will be seen in the office within one week of
      discharge and fluid aspirated from each expander using the reservoir ports, and the volume
      shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or
      the amount of fluid aspirated is less than 10 cc.

      Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their
      attitudes about their breast reconstruction, first at completion of tissue expansion and
      finally at their first follow-up visit following placement of permanent breast implants.

      This study utilizes FDA 510k-classified devices that allow removal of fluid without drains,
      in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with successful breast reconstruction using reservoir-expanders
time frame: 4-6 months
description: The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.
arm group label: All patients in study
description: 5 consecutive patients with breast cancer or a breast cancer-causing gene that elect to undergo bilateral breast reconstruction will be Insertion of Tissue Expander with Fluid Reservoir as the first stage of reconstruction. Post-surgical care will be similar as patients with conventional expanders, except that during office visits, fluid will be transcutaneously aspirated from the fluid reservoir on each side.
intervention type: Device
intervention name: Insertion of Tissue Expander with Fluid Reservoir
description: Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.
arm group label: All patients in study
other name: Sientra AlloX2 Expander
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female breast cancer patients are usually candidates for reconstruction using breast implants
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Edward C Ray, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
citation: Smith JM, Broyles JM, Guo Y, Tuffaha SH, Mathes D, Sacks JM. Human acellular dermis increases surgical site infection and overall complication profile when compared with submuscular breast reconstruction: An updated meta-analysis incorporating new products✰. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556. doi: 10.1016/j.bjps.2018.06.012. Epub 2018 Jul 6.
PMID: 30093286
citation: Kim JYS, Davila AA, Persing S, Connor CM, Jovanovic B, Khan SA, Fine N, Rawlani V. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012 Jan;129(1):28-41. doi: 10.1097/PRS.0b013e3182361fd6.
PMID: 22186498
citation: Ollech CJ, Block LM, Afifi AM, Poore SO. Effect of Drain Placement on Infection, Seroma, and Return to Operating Room in Expander-Based Breast Reconstruction. Ann Plast Surg. 2017 Dec;79(6):536-540. doi: 10.1097/SAP.0000000000001174.
PMID: 28671886
citation: Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31.
PMID: 23346164
citation: Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.
PMID: 22693384
citation: Murray JD, Elwood ET, Jones GE, Barrick R, Feng J. Decreasing expander breast infection: A new drain care protocol. Can J Plast Surg. 2009 Spring;17(1):17-21.
PMID: 20190908
citation: Carcoforo P, Soliani G, Maestroni U, Donini A, Inderbitzin D, Hui TT, Lefor A, Avital I, Navarra G. Octreotide in the treatment of lymphorrhea after axillary node dissection: a prospective randomized controlled trial. J Am Coll Surg. 2003 Mar;196(3):365-9. doi: 10.1016/S1072-7515(02)01757-X.
PMID: 12648685
citation: Park JE, Nigam M, Shenaq DS, Song DH. A simple, safe technique for thorough seroma evacuation in the outpatient setting. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e212. doi: 10.1097/GOX.0000000000000179. eCollection 2014 Sep.
PMID: 25426395
citation: Puttawibul P, Sangthong B, Maipang T, Sampao S, Uttamakul P, Apakupakul N. Mastectomy without drain at pectoral area: a randomized controlled trial. J Med Assoc Thai. 2003 Apr;86(4):325-31.
PMID: 12757076
citation: Rose JF, Zafar SN, Ellsworth Iv WA. Does Acellular Dermal Matrix Thickness Affect Complication Rate in Tissue Expander Based Breast Reconstruction? Plast Surg Int. 2016;2016:2867097. doi: 10.1155/2016/2867097. Epub 2016 Apr 12.
PMID: 27190645
citation: Zeidler KR, Capizzi PJ, Pittman TA. Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):29S-39S. doi: 10.1097/PRS.0000000000004352.
PMID: 29595716
citation: Moyer KE, Potochny JD. Technique for seroma drainage in implant-based breast reconstruction. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1614-7. doi: 10.1016/j.bjps.2012.06.016. Epub 2012 Jul 6.
PMID: 22770571
citation: Jordan SW, Khavanin N, Kim JYS. Seroma in Prosthetic Breast Reconstruction. Plast Reconstr Surg. 2016 Apr;137(4):1104-1116. doi: 10.1097/01.prs.0000481102.24444.72.
PMID: 27018665
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Edward Ray
investigator title: Staff Physician II
mesh term: Hereditary Breast and Ovarian Cancer Syndrome
sharing ipd: No