<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/NCT03282058</url>
  </required_header>
  <id_info>
    <org_study_id>H14-02101</org_study_id>
    <nct_id>NCT03282058</nct_id>
  </id_info>
  <brief_title>Silastic Stent Study</brief_title>
  <official_title>The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</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>
      Endoscopic skull base surgery is a relatively new procedure that is now a standard of care&#xD;
      for surgeries at the base of the skull; however there are no studies that examine the healing&#xD;
      process of the nasal lining with the use of silastic (silicone) stents (or splints) that&#xD;
      might be placed at the time of surgery. While there is some evidence to suggest that the use&#xD;
      of stents improves wound healing, the decision to use a stent or not is currently up to the&#xD;
      preference of the surgeon. To investigate the impact of stents on post-surgical healing, the&#xD;
      investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal&#xD;
      pituitary surgeries with septal flap reconstruction with the use of silastic stents to line&#xD;
      the septal donor site, and compare their recovery to those who did not receive stents. The&#xD;
      investigators hypothesize that the use of silastic stents in endonasal surgery increases the&#xD;
      rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the&#xD;
      patients experience after surgery. In this randomized control trial the investigators aim to&#xD;
      recruit 26 (13 in each arm) study participants. The primary outcome is to determine the&#xD;
      effect of silastic stunting on healing of the naso-septal flap donor site. This objective&#xD;
      will be achieved by assessment of endoscopic photographs of healing tissue and histologic&#xD;
      assessment of healing tissues. The secondary outcome involves questionnaires that measure the&#xD;
      patient's subjective nasal symptoms prior to and following endoscopic skull based surgery.&#xD;
      Total time commitment for the study participant is about 4 months across 4 study visits (all&#xD;
      of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative&#xD;
      follow up visit and 12 week post-operative follow up visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 4, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Participants will be randomly assigned in one of two groups (stent vs no stent).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Histology of the healing tissues will be examined by a pathologist who is blinded to whether the patient received or did not receive stenting.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.</measure>
    <time_frame>Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)</time_frame>
    <description>Visual assessment of endoscopic photographs of healing tissue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determining the effect of silastic stunting on microscopic level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.</measure>
    <time_frame>Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)</time_frame>
    <description>Histologic assessment of healing tissues.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.</measure>
    <time_frame>Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)</time_frame>
    <description>Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective post-operative outcomes following endoscopic skull based surgery.</measure>
    <time_frame>Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)</time_frame>
    <description>Participants will fill out a post-operative rating scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.</measure>
    <time_frame>Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)</time_frame>
    <description>Physician will fill out an outcome measures evaluation scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Pituitary Tumour</condition>
  <arm_group>
    <arm_group_label>Silastic Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the time of surgery, if the patient is identified in the &quot;silastic stent&quot; arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Stent</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At the time of surgery, if the patient is identified in the &quot;no silastic stent&quot; arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Silastic Stent</intervention_name>
    <description>The silastic stent is a splint made of silicone.</description>
    <arm_group_label>Silastic Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first&#xD;
             post-operative appointment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with inflammatory sinus conditions&#xD;
&#xD;
          -  patients having undergone extensive skull base reconstructions&#xD;
&#xD;
          -  patients having received previous radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arif Janjua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <reference>
    <citation>Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.</citation>
    <PMID>19909864</PMID>
  </reference>
  <reference>
    <citation>Cowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.</citation>
  </reference>
  <reference>
    <citation>Gamoletti R, Lanzarini P, Sanna M, Zini C. Regenerated middle ear mucosa after tympanoplasty. Part II. Scanning electron microscopy. Otolaryngol Head Neck Surg. 1986 Apr;94(4):430-4. doi: 10.1177/019459988609400404.</citation>
    <PMID>3086802</PMID>
  </reference>
  <reference>
    <citation>Ng M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102. doi: 10.1288/00005537-199210000-00002.</citation>
    <PMID>1328786</PMID>
  </reference>
  <reference>
    <citation>Soper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc</citation>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Arif Janjua</investigator_full_name>
    <investigator_title>MD, FRCSC, Otolarynology - Head &amp; Neck Surgery; Endoscopic Sinus &amp; Skull Based Surgery</investigator_title>
  </responsible_party>
  <keyword>Silastic Stenting</keyword>
  <keyword>Trans-nasal Endoscopic Surgery</keyword>
  <keyword>Post-operative Intra-nasal Re-mucosalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pituitary Neoplasms</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/NCT03282058
org study id: H14-02101
nct id: NCT03282058
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic skull base surgery is a relatively new procedure that is now a standard of care
      for surgeries at the base of the skull; however there are no studies that examine the healing
      process of the nasal lining with the use of silastic (silicone) stents (or splints) that
      might be placed at the time of surgery. While there is some evidence to suggest that the use
      of stents improves wound healing, the decision to use a stent or not is currently up to the
      preference of the surgeon. To investigate the impact of stents on post-surgical healing, the
      investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal
      pituitary surgeries with septal flap reconstruction with the use of silastic stents to line
      the septal donor site, and compare their recovery to those who did not receive stents. The
      investigators hypothesize that the use of silastic stents in endonasal surgery increases the
      rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the
      patients experience after surgery. In this randomized control trial the investigators aim to
      recruit 26 (13 in each arm) study participants. The primary outcome is to determine the
      effect of silastic stunting on healing of the naso-septal flap donor site. This objective
      will be achieved by assessment of endoscopic photographs of healing tissue and histologic
      assessment of healing tissues. The secondary outcome involves questionnaires that measure the
      patient's subjective nasal symptoms prior to and following endoscopic skull based surgery.
      Total time commitment for the study participant is about 4 months across 4 study visits (all
      of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative
      follow up visit and 12 week post-operative follow up visit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned in one of two groups (stent vs no stent).
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Histology of the healing tissues will be examined by a pathologist who is blinded to whether the patient received or did not receive stenting.
measure: Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
description: Visual assessment of endoscopic photographs of healing tissue.
measure: Determining the effect of silastic stunting on microscopic level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
description: Histologic assessment of healing tissues.
measure: Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.
time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
description: Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22).
measure: Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective post-operative outcomes following endoscopic skull based surgery.
time frame: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)
description: Participants will fill out a post-operative rating scale.
measure: Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.
time frame: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)
description: Physician will fill out an outcome measures evaluation scale.
arm group label: Silastic Stent
arm group type: Experimental
description: At the time of surgery, if the patient is identified in the "silastic stent" arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely.
arm group label: No Stent
arm group type: No Intervention
description: At the time of surgery, if the patient is identified in the "no silastic stent" arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care.
intervention type: Device
intervention name: Silastic Stent
description: The silastic stent is a splint made of silicone.
arm group label: Silastic Stent
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Arif Janjua, MD
role: Principal Investigator
affiliation: University of British Columbia
citation: Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.
PMID: 19909864
citation: Cowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.
citation: Gamoletti R, Lanzarini P, Sanna M, Zini C. Regenerated middle ear mucosa after tympanoplasty. Part II. Scanning electron microscopy. Otolaryngol Head Neck Surg. 1986 Apr;94(4):430-4. doi: 10.1177/019459988609400404.
PMID: 3086802
citation: Ng M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102. doi: 10.1288/00005537-199210000-00002.
PMID: 1328786
citation: Soper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Arif Janjua
investigator title: MD, FRCSC, Otolarynology - Head & Neck Surgery; Endoscopic Sinus & Skull Based Surgery
mesh term: Pituitary Neoplasms
sharing ipd: No