<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/NCT04457765</url>
  </required_header>
  <id_info>
    <org_study_id>H-40432</org_study_id>
    <nct_id>NCT04457765</nct_id>
  </id_info>
  <brief_title>Betadine Effect on Nasal Mucosa Cilia</brief_title>
  <official_title>Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the proposed study is to identify PVP-I at 1.25% as an appropriate intranasal&#xD;
      topical preparation for patients undergoing rhinoplasty with no effect on the nasal mucosa&#xD;
      cilia (NMC) or olfaction using the saccharin transit time (STT) test as a method for&#xD;
      evaluating NMC function. PVP-I has been shown to be viricidal in the upper aerodigestive&#xD;
      tract. This study is highly-relevant, as protection for individuals with a high risk of&#xD;
      exposure to respiratory pathogens has become increasingly important in the setting of recent&#xD;
      viral epidemics such as SARS-CoV-2. Septorhinoplasty is commonly performed throughout the&#xD;
      world and there is a paucity of standardized testing in surgical facilities. Much of our&#xD;
      understanding of the current COVID-19 pandemic is extrapolated from MERS and SARS data. It is&#xD;
      our hope that this study's relevance for the current pandemic remains so in the unfortunate&#xD;
      event of another pandemic in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The IRB did not approve the study to be conducted at the home institution.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2021</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative nasal mucosa cilia (NMC) function</measure>
    <time_frame>baseline</time_frame>
    <description>NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT &gt;30.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative nasal mucosa cilia (NMC) function</measure>
    <time_frame>5 weeks</time_frame>
    <description>NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT &gt;30.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self reported symptoms of nasal blockage or obstruction</measure>
    <time_frame>baseline, 5 weeks</time_frame>
    <description>Nasal symptoms will be assessed with the NOSE (Nasal Obstruction Symptom Evaluation) Tool. NOSE has 5 questions and response options for each range from 0 to 4 where 0= Not a problem, 1= Mild problem, 2= Moderate problem, 3= Significant problem, 4= Severe problem. The response value for each question is multiplied by 5 so overall NOSE scores can range from 0 to 100 and are interpreted as-- 0: Nothing to worry about; 5 - 25: Mild obstruction; 26 - 50: Moderate obstruction; 51 - 75: Significant obstruction; 76 - 100: Severe obstruction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in olfactory function</measure>
    <time_frame>baseline, 5 weeks</time_frame>
    <description>The participant will be instructed to sniff repetitively and to tell when an odor is detected, identifying the odor if recognized. The test odor up to within 30 cm or less of the nose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life based on sino-nasal symptoms</measure>
    <time_frame>baseline, 5 weeks</time_frame>
    <description>Participants' quality of life will be assessed using the Sino-nasal Outcome Test (SNOT-22). This is a self administered questionnaire with 22 items. Each items is answered by selecting one of 6 categories where 0 = No problem, 1 = Very Mild problem, 2 = Mild or slight problem, 3 = Moderate problem, 4 = Severe problem, 5 = Problem as bad as it can be. Scores can range from 0 to 110. A score of 7 or below is considered 'normal' scores 8 or above suggests that sino-nasal symptoms are affecting participants' quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative clinical examination of nasal mucosa</measure>
    <time_frame>baseline</time_frame>
    <description>A through preoperative clinical examination of each participant will be done and findings documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative clinical examination of nasal mucosa</measure>
    <time_frame>5 weeks</time_frame>
    <description>A through postoperative clinical examination of each participant will be done and findings documented.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Rhinoplasty</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-Iodine (PVP-I)</intervention_name>
    <description>1.25% Povidone-Iodine (PVP-I) (also known as betadine) to be used pre-procedure in the operating room via irrigation into the nasal cavity to act as viricidal preparation for the procedure. 240mL of 1.25% PVP-I will be distributed evenly among the right and left nasal cavities using a a 70mL syringe.</description>
    <arm_group_label>group 1</arm_group_label>
    <other_name>Betadine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at Boston Medical Center undergoing septorhinoplasty, without inferior&#xD;
             turbinate reduction&#xD;
&#xD;
          -  Normal range baseline saccharin transit time (STT)&#xD;
&#xD;
          -  SARS-CoV-2 Testing Negative at the time of the procedure o Per institution guidelines,&#xD;
             patients scheduled for surgery undergo a preoperative nasopharyngeal test within 24&#xD;
             hours of their procedure - per institution protocols.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of:&#xD;
&#xD;
               -  thyroid dysfunction&#xD;
&#xD;
               -  renal disease&#xD;
&#xD;
               -  autoimmune disease affecting the upper airway&#xD;
&#xD;
               -  immunocompromised&#xD;
&#xD;
               -  pregnant, breastfeeding&#xD;
&#xD;
          -  Patients determined to have dysfunctional nasal mucosa cilia (NMC) function based on a&#xD;
             STT time of ≥30 minutes&#xD;
&#xD;
          -  Patients with a contraindication to Povidone-iodine (PVP-I) including history of&#xD;
             allergy/anaphylaxis to PVP-I, labile thyroid disease, history of contact dermatitis,&#xD;
             active radioiodine therapy, pregnancy/nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waleed Ezzat, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Shehan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Septorhioplasty</keyword>
  <keyword>Povidine-Iodine (PVP-I)</keyword>
  <keyword>Betadine</keyword>
  <keyword>Nasal mucosa cilia (NMC)</keyword>
  <keyword>Saccharin transit time (STT)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_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/NCT04457765
org study id: H-40432
nct id: NCT04457765
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The goal of the proposed study is to identify PVP-I at 1.25% as an appropriate intranasal
      topical preparation for patients undergoing rhinoplasty with no effect on the nasal mucosa
      cilia (NMC) or olfaction using the saccharin transit time (STT) test as a method for
      evaluating NMC function. PVP-I has been shown to be viricidal in the upper aerodigestive
      tract. This study is highly-relevant, as protection for individuals with a high risk of
      exposure to respiratory pathogens has become increasingly important in the setting of recent
      viral epidemics such as SARS-CoV-2. Septorhinoplasty is commonly performed throughout the
      world and there is a paucity of standardized testing in surgical facilities. Much of our
      understanding of the current COVID-19 pandemic is extrapolated from MERS and SARS data. It is
      our hope that this study's relevance for the current pandemic remains so in the unfortunate
      event of another pandemic in the future.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Preoperative nasal mucosa cilia (NMC) function
time frame: baseline
description: NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT >30.
measure: Postoperative nasal mucosa cilia (NMC) function
time frame: 5 weeks
description: NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT >30.
measure: Change in self reported symptoms of nasal blockage or obstruction
time frame: baseline, 5 weeks
description: Nasal symptoms will be assessed with the NOSE (Nasal Obstruction Symptom Evaluation) Tool. NOSE has 5 questions and response options for each range from 0 to 4 where 0= Not a problem, 1= Mild problem, 2= Moderate problem, 3= Significant problem, 4= Severe problem. The response value for each question is multiplied by 5 so overall NOSE scores can range from 0 to 100 and are interpreted as-- 0: Nothing to worry about; 5 - 25: Mild obstruction; 26 - 50: Moderate obstruction; 51 - 75: Significant obstruction; 76 - 100: Severe obstruction.
measure: Change in olfactory function
time frame: baseline, 5 weeks
description: The participant will be instructed to sniff repetitively and to tell when an odor is detected, identifying the odor if recognized. The test odor up to within 30 cm or less of the nose.
measure: Change in quality of life based on sino-nasal symptoms
time frame: baseline, 5 weeks
description: Participants' quality of life will be assessed using the Sino-nasal Outcome Test (SNOT-22). This is a self administered questionnaire with 22 items. Each items is answered by selecting one of 6 categories where 0 = No problem, 1 = Very Mild problem, 2 = Mild or slight problem, 3 = Moderate problem, 4 = Severe problem, 5 = Problem as bad as it can be. Scores can range from 0 to 110. A score of 7 or below is considered 'normal' scores 8 or above suggests that sino-nasal symptoms are affecting participants' quality of life.
measure: Preoperative clinical examination of nasal mucosa
time frame: baseline
description: A through preoperative clinical examination of each participant will be done and findings documented.
measure: Post operative clinical examination of nasal mucosa
time frame: 5 weeks
description: A through postoperative clinical examination of each participant will be done and findings documented.
arm group label: group 1
arm group type: Experimental
description: All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty
intervention type: Drug
intervention name: Povidone-Iodine (PVP-I)
description: 1.25% Povidone-Iodine (PVP-I) (also known as betadine) to be used pre-procedure in the operating room via irrigation into the nasal cavity to act as viricidal preparation for the procedure. 240mL of 1.25% PVP-I will be distributed evenly among the right and left nasal cavities using a a 70mL syringe.
arm group label: group 1
other name: Betadine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Waleed Ezzat, MD
role: Study Chair
affiliation: Boston Medical Center
last name: Jennifer Shehan, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: No