<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/NCT04506255</url>
  </required_header>
  <id_info>
    <org_study_id>1025794</org_study_id>
    <nct_id>NCT04506255</nct_id>
  </id_info>
  <brief_title>Silicone Taping for the Improvement of Abdominal Donor Site Scars</brief_title>
  <official_title>Silicone Taping for the Improvement of Abdominal Donor Site Scars Following Autologous Breast Reconstruction; A Randomized, Prospective Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</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 will look at silicone tape compared to the current no dressing standard at the&#xD;
      investigators institution, to determine if silicone tape provides a significant improvement&#xD;
      in post-abdominoplasty scar appearance. Silicone tape will be added to half of the&#xD;
      abdominoplasty incision of patients undergoing abdominally-based breast reconstruction&#xD;
      procedures two weeks after their operation. They will be followed up and assessed at specific&#xD;
      timepoints to determine whether the silicone improves scar outcomes in these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single center, masked, randomized self-controlled clinical human trial&#xD;
      to evaluate the appearance of abdominal scars after autologous free-flap breast&#xD;
      reconstruction following post-operative application of silicone tape to improve scar quality.&#xD;
      Incisions from 32 adult subjects will act as their own control and will be randomized to have&#xD;
      silicone tape applied to one half of their abdominoplasty incision and control treatment&#xD;
      using the current standard of care at the investigators institution to the other half, which&#xD;
      is no dressing after the initial two week post-op period. A participant size of 32 leaves&#xD;
      room in case of participant loss to follow-up, ensuring data will be available for the&#xD;
      required sample size of 28 (see statistical analysis section below). A random number sequence&#xD;
      generator will be used to randomize which half of the patient's wound will receive the&#xD;
      treatment.&#xD;
&#xD;
      Patients will be recruited from plastic surgery clinics at the Queen Elizabeth II (QEII)&#xD;
      Health Sciences Centre in Halifax, Nova Scotia. Plastic surgeons will be asked to participate&#xD;
      and enroll their breast reconstruction patients, who will undergo a type of abdominoplasty as&#xD;
      part of their reconstruction procedure.&#xD;
&#xD;
      Patients will undergo a de novo abdominoplasty procedure as part of a reconstructive breast&#xD;
      surgery. Two weeks post-operatively, one side of the patient's abdominoplasty incision will&#xD;
      be randomized to receive the silicone tape and the remaining half will be left to heal&#xD;
      without any dressing application, which is the current standard at the investigators&#xD;
      institution. Each patient will act as their own control. Patients will apply silicone tape on&#xD;
      a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied&#xD;
      after drying. Total length of treatment will be two and a half months.&#xD;
&#xD;
      It is not possible to mask patients, as they will be responsible for ongoing application of&#xD;
      the silicone tape. However, the staff surgeon will be masked. Patients will present to their&#xD;
      first post-op visit at two weeks. After examination by the staff surgeon, the patient will be&#xD;
      seen by the research coordinator who will provide the patient with their randomization&#xD;
      treatment assignment. To ensure ongoing masking, at subsequent follow-up visits, patients&#xD;
      will remove their dressings one day prior to their appointment with their surgeon. This will&#xD;
      ensure no local reaction (i.e. redness after tape removal) that would compromise the masking&#xD;
      of staff surgeons.&#xD;
&#xD;
      Patients will then follow up for scar assessment at 6 weeks, 3 months, 6 months and 12&#xD;
      months. Unless otherwise required, scar assessments will then be performed at each visit by&#xD;
      both the patient and the surgeon using validated objective and subjective scar measures.&#xD;
      Patients will also meet with the research coordinator at each follow up visit, to address any&#xD;
      questions or concerns about the study and treatment.&#xD;
&#xD;
      The Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) system will be used to measure&#xD;
      scar appearance. The PSAS and OSAS are tools that the patient uses to assess the scar on&#xD;
      color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon&#xD;
      uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and&#xD;
      overall opinion (Appendix A). Of note, only the sum of the components of the OSAS portion of&#xD;
      the assessment scale is included to calculate the power and sample size, and will therefore&#xD;
      be the primary outcome. Secondary outcomes will include the sum of the components of the PSAS&#xD;
      score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked&#xD;
      surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 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>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective, single center, masked, randomized self-controlled clinical human trial to evaluate the appearance of abdominal scars after autologous free-flap breast reconstruction following post-operative application of silicone tape to improve scar quality.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Staff surgeons who are responsible for assessing outcomes will be masked to which side is receiving the silicone tape. At the initial two-week post-op visit, patients will meet with the research coordinator for randomization assignments of their incisions. Surgeons will be masked to assignments. Patients will remove their dressings one day prior to their appointment with their surgeon. This will ensure no local reaction (i.e. redness after tape removal) that would compromise the masking of staff surgeons.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>6 week follow up, 3 months, 6 months and 12 months.</time_frame>
    <description>The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>3 month follow up</time_frame>
    <description>The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>6 month follow up</time_frame>
    <description>The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>12 month follow up</time_frame>
    <description>The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>6 week follow up</time_frame>
    <description>Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>3 month follow up</time_frame>
    <description>Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>6 month follow up</time_frame>
    <description>Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (PSAS &amp; OSAS) System</measure>
    <time_frame>12 month follow up</time_frame>
    <description>Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Hypertrophic Scar</condition>
  <condition>Scar</condition>
  <arm_group>
    <arm_group_label>Silicone tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult subjects will act as their own control and will be randomized to have silicone tape applied to one half of their abdominoplasty incision. Patients will apply silicone tape on a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied after drying. Total length of treatment will be two and a half months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No dressing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control treatment using the current standard of care at our institution to the other half, which is no dressing after the initial two week post-op period, will be used on the other half of the incision for comparison. Each individual patient will act as their own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Silicone tape</intervention_name>
    <description>Medical grade tape with silicone adhesive</description>
    <arm_group_label>Silicone tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing de novo abdominoplasty procedures as part of their breast reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of collagen disease, connective tissue disorders, psoriasis or&#xD;
             lupus&#xD;
&#xD;
          -  patients with scleroderma&#xD;
&#xD;
          -  patients with a history of adverse reaction to adhesives or silicone allergy&#xD;
&#xD;
          -  patients with signs of dehiscence or infection resulting in modification to the&#xD;
             experimental or control dressings&#xD;
&#xD;
          -  patients who are unable to care for their incisions&#xD;
&#xD;
          -  patients who are current smokers&#xD;
&#xD;
          -  patients who are currently on steroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason G Williams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jason G Williams, MD</last_name>
    <phone>902-473-6315</phone>
    <email>Jason.Williams@nshealth.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emily Burke, MD</last_name>
    <phone>902-694-8080</phone>
    <email>Emily.Burke@dal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Halifax Infirmary</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Williams</last_name>
      <phone>902-473-6315</phone>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.</citation>
    <PMID>24804638</PMID>
  </reference>
  <reference>
    <citation>Bleasdale B, Finnegan S, Murray K, Kelly S, Percival SL. The Use of Silicone Adhesives for Scar Reduction. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):422-430. doi: 10.1089/wound.2015.0625.</citation>
    <PMID>26155385</PMID>
  </reference>
  <reference>
    <citation>Hsu KC, Luan CW, Tsai YW. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Keloids. Wounds. 2017 May;29(5):154-158.</citation>
    <PMID>28570253</PMID>
  </reference>
  <reference>
    <citation>Sidgwick GP, McGeorge D, Bayat A. A comprehensive evidence-based review on the role of topicals and dressings in the management of skin scarring. Arch Dermatol Res. 2015 Aug;307(6):461-77. doi: 10.1007/s00403-015-1572-0. Epub 2015 Jun 5.</citation>
    <PMID>26044054</PMID>
  </reference>
  <reference>
    <citation>Meaume S, Le Pillouer-Prost A, Richert B, Roseeuw D, Vadoud J. Management of scars: updated practical guidelines and use of silicones. Eur J Dermatol. 2014 Jul-Aug;24(4):435-43. doi: 10.1684/ejd.2014.2356.</citation>
    <PMID>25141160</PMID>
  </reference>
  <reference>
    <citation>Finnerty CC, Jeschke MG, Branski LK, Barret JP, Dziewulski P, Herndon DN. Hypertrophic scarring: the greatest unmet challenge after burn injury. Lancet. 2016 Oct 1;388(10052):1427-1436. doi: 10.1016/S0140-6736(16)31406-4.</citation>
    <PMID>27707499</PMID>
  </reference>
  <reference>
    <citation>Lorenz HP, Adzick NS. Scarless skin wound repair in the fetus. West J Med. 1993 Sep;159(3):350-5.</citation>
    <PMID>8236977</PMID>
  </reference>
  <reference>
    <citation>Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.</citation>
    <PMID>18480812</PMID>
  </reference>
  <reference>
    <citation>Mustoe TA. Evolution of silicone therapy and mechanism of action in scar management. Aesthetic Plast Surg. 2008 Jan;32(1):82-92. doi: 10.1007/s00266-007-9030-9. Epub 2007 Oct 30.</citation>
    <PMID>17968615</PMID>
  </reference>
  <reference>
    <citation>Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.</citation>
    <PMID>12142678</PMID>
  </reference>
  <reference>
    <citation>O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.</citation>
    <PMID>24030657</PMID>
  </reference>
  <reference>
    <citation>van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.</citation>
    <PMID>16079683</PMID>
  </reference>
  <reference>
    <citation>Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.</citation>
    <PMID>15253184</PMID>
  </reference>
  <reference>
    <citation>Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.</citation>
    <PMID>17230080</PMID>
  </reference>
  <reference>
    <citation>Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.</citation>
    <PMID>20596233</PMID>
  </reference>
  <reference>
    <citation>Khoo TL, Halim AS, Zakaria Z, Mat Saad AZ, Wu LY, Lau HY. A prospective, randomised, double-blinded trial to study the efficacy of topical tocotrienol in the prevention of hypertrophic scars. J Plast Reconstr Aesthet Surg. 2011 Jun;64(6):e137-45. doi: 10.1016/j.bjps.2010.08.029. Epub 2010 Sep 24.</citation>
    <PMID>20869928</PMID>
  </reference>
  <reference>
    <citation>Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.</citation>
    <PMID>25619206</PMID>
  </reference>
  <reference>
    <citation>Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.</citation>
    <PMID>31442535</PMID>
  </reference>
  <reference>
    <citation>Duncan JAL, Bond JS, Mason T, Ludlow A, Cridland P, O'Kane S, Ferguson MWJ. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006 Sep 15;118(4):909-918. doi: 10.1097/01.prs.0000232378.88776.b0.</citation>
    <PMID>16980850</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Jason Williams</investigator_full_name>
    <investigator_title>Principal Investigation</investigator_title>
  </responsible_party>
  <keyword>Silicone</keyword>
  <keyword>Scar</keyword>
  <keyword>Abdominoplasty</keyword>
  <keyword>Breast Reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</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/NCT04506255
org study id: 1025794
nct id: NCT04506255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will look at silicone tape compared to the current no dressing standard at the
      investigators institution, to determine if silicone tape provides a significant improvement
      in post-abdominoplasty scar appearance. Silicone tape will be added to half of the
      abdominoplasty incision of patients undergoing abdominally-based breast reconstruction
      procedures two weeks after their operation. They will be followed up and assessed at specific
      timepoints to determine whether the silicone improves scar outcomes in these patients.
This is a prospective, single center, masked, randomized self-controlled clinical human trial
      to evaluate the appearance of abdominal scars after autologous free-flap breast
      reconstruction following post-operative application of silicone tape to improve scar quality.
      Incisions from 32 adult subjects will act as their own control and will be randomized to have
      silicone tape applied to one half of their abdominoplasty incision and control treatment
      using the current standard of care at the investigators institution to the other half, which
      is no dressing after the initial two week post-op period. A participant size of 32 leaves
      room in case of participant loss to follow-up, ensuring data will be available for the
      required sample size of 28 (see statistical analysis section below). A random number sequence
      generator will be used to randomize which half of the patient's wound will receive the
      treatment.

      Patients will be recruited from plastic surgery clinics at the Queen Elizabeth II (QEII)
      Health Sciences Centre in Halifax, Nova Scotia. Plastic surgeons will be asked to participate
      and enroll their breast reconstruction patients, who will undergo a type of abdominoplasty as
      part of their reconstruction procedure.

      Patients will undergo a de novo abdominoplasty procedure as part of a reconstructive breast
      surgery. Two weeks post-operatively, one side of the patient's abdominoplasty incision will
      be randomized to receive the silicone tape and the remaining half will be left to heal
      without any dressing application, which is the current standard at the investigators
      institution. Each patient will act as their own control. Patients will apply silicone tape on
      a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied
      after drying. Total length of treatment will be two and a half months.

      It is not possible to mask patients, as they will be responsible for ongoing application of
      the silicone tape. However, the staff surgeon will be masked. Patients will present to their
      first post-op visit at two weeks. After examination by the staff surgeon, the patient will be
      seen by the research coordinator who will provide the patient with their randomization
      treatment assignment. To ensure ongoing masking, at subsequent follow-up visits, patients
      will remove their dressings one day prior to their appointment with their surgeon. This will
      ensure no local reaction (i.e. redness after tape removal) that would compromise the masking
      of staff surgeons.

      Patients will then follow up for scar assessment at 6 weeks, 3 months, 6 months and 12
      months. Unless otherwise required, scar assessments will then be performed at each visit by
      both the patient and the surgeon using validated objective and subjective scar measures.
      Patients will also meet with the research coordinator at each follow up visit, to address any
      questions or concerns about the study and treatment.

      The Patient and Observer Scar Assessment Scale (PSAS & OSAS) system will be used to measure
      scar appearance. The PSAS and OSAS are tools that the patient uses to assess the scar on
      color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon
      uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and
      overall opinion (Appendix A). Of note, only the sum of the components of the OSAS portion of
      the assessment scale is included to calculate the power and sample size, and will therefore
      be the primary outcome. Secondary outcomes will include the sum of the components of the PSAS
      score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked
      surgeon.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This is a prospective, single center, masked, randomized self-controlled clinical human trial to evaluate the appearance of abdominal scars after autologous free-flap breast reconstruction following post-operative application of silicone tape to improve scar quality.
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: Staff surgeons who are responsible for assessing outcomes will be masked to which side is receiving the silicone tape. At the initial two-week post-op visit, patients will meet with the research coordinator for randomization assignments of their incisions. Surgeons will be masked to assignments. Patients will remove their dressings one day prior to their appointment with their surgeon. This will ensure no local reaction (i.e. redness after tape removal) that would compromise the masking of staff surgeons.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 6 week follow up, 3 months, 6 months and 12 months.
description: The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 3 month follow up
description: The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 6 month follow up
description: The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 12 month follow up
description: The POSAS is a tool that the patient uses to assess the scar on color, irregularity, itch, pain, thickness, stiffness and overall opinion, and the surgeon uses to assess pigmentation, pliability, relief, surface area, thickness, vascularity and overall opinion. Each component is scored out of 10, with a lower score indicating a better scar. Of note, only the sum of the components of the OSAS portion of the assessment scale is included to calculate the power and sample size, and will therefore be the primary outcome.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 6 week follow up
description: Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 3 month follow up
description: Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 6 month follow up
description: Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.
measure: Patient and Observer Scar Assessment Scale (PSAS & OSAS) System
time frame: 12 month follow up
description: Secondary outcomes will include the sum of the components of the PSAS score and the overall scores out of 10 for both the PSAS and OSAS from the patient and masked surgeon. A lower score in each component indicates an improved scar.
arm group label: Silicone tape
arm group type: Experimental
description: Adult subjects will act as their own control and will be randomized to have silicone tape applied to one half of their abdominoplasty incision. Patients will apply silicone tape on a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied after drying. Total length of treatment will be two and a half months.
arm group label: No dressing
arm group type: No Intervention
description: Control treatment using the current standard of care at our institution to the other half, which is no dressing after the initial two week post-op period, will be used on the other half of the incision for comparison. Each individual patient will act as their own control.
intervention type: Device
intervention name: Silicone tape
description: Medical grade tape with silicone adhesive
arm group label: Silicone tape
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jason G Williams, MD
role: Principal Investigator
affiliation: Nova Scotia Health Authority
last name: Jason G Williams, MD
phone: 902-473-6315
email: Jason.Williams@nshealth.ca
last name: Emily Burke, MD
phone: 902-694-8080
email: Emily.Burke@dal.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.
PMID: 24804638
citation: Bleasdale B, Finnegan S, Murray K, Kelly S, Percival SL. The Use of Silicone Adhesives for Scar Reduction. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):422-430. doi: 10.1089/wound.2015.0625.
PMID: 26155385
citation: Hsu KC, Luan CW, Tsai YW. Review of Silicone Gel Sheeting and Silicone Gel for the Prevention of Hypertrophic Scars and Keloids. Wounds. 2017 May;29(5):154-158.
PMID: 28570253
citation: Sidgwick GP, McGeorge D, Bayat A. A comprehensive evidence-based review on the role of topicals and dressings in the management of skin scarring. Arch Dermatol Res. 2015 Aug;307(6):461-77. doi: 10.1007/s00403-015-1572-0. Epub 2015 Jun 5.
PMID: 26044054
citation: Meaume S, Le Pillouer-Prost A, Richert B, Roseeuw D, Vadoud J. Management of scars: updated practical guidelines and use of silicones. Eur J Dermatol. 2014 Jul-Aug;24(4):435-43. doi: 10.1684/ejd.2014.2356.
PMID: 25141160
citation: Finnerty CC, Jeschke MG, Branski LK, Barret JP, Dziewulski P, Herndon DN. Hypertrophic scarring: the greatest unmet challenge after burn injury. Lancet. 2016 Oct 1;388(10052):1427-1436. doi: 10.1016/S0140-6736(16)31406-4.
PMID: 27707499
citation: Lorenz HP, Adzick NS. Scarless skin wound repair in the fetus. West J Med. 1993 Sep;159(3):350-5.
PMID: 8236977
citation: Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.
PMID: 18480812
citation: Mustoe TA. Evolution of silicone therapy and mechanism of action in scar management. Aesthetic Plast Surg. 2008 Jan;32(1):82-92. doi: 10.1007/s00266-007-9030-9. Epub 2007 Oct 30.
PMID: 17968615
citation: Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.
PMID: 12142678
citation: O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
PMID: 24030657
citation: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PMID: 16079683
citation: Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PMID: 15253184
citation: Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.
PMID: 17230080
citation: Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PMID: 20596233
citation: Khoo TL, Halim AS, Zakaria Z, Mat Saad AZ, Wu LY, Lau HY. A prospective, randomised, double-blinded trial to study the efficacy of topical tocotrienol in the prevention of hypertrophic scars. J Plast Reconstr Aesthet Surg. 2011 Jun;64(6):e137-45. doi: 10.1016/j.bjps.2010.08.029. Epub 2010 Sep 24.
PMID: 20869928
citation: Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.
PMID: 25619206
citation: Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.
PMID: 31442535
citation: Duncan JAL, Bond JS, Mason T, Ludlow A, Cridland P, O'Kane S, Ferguson MWJ. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006 Sep 15;118(4):909-918. doi: 10.1097/01.prs.0000232378.88776.b0.
PMID: 16980850
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Jason Williams
investigator title: Principal Investigation
mesh term: Cicatrix
mesh term: Cicatrix, Hypertrophic
sharing ipd: No