<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/NCT02190162</url>
  </required_header>
  <id_info>
    <org_study_id>0028-14-NHR</org_study_id>
    <nct_id>NCT02190162</nct_id>
  </id_info>
  <brief_title>The Influence of Tantum Verde® on Recovery Following Tonsillectomy</brief_title>
  <official_title>A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effects of Tantum Verde® for improving recovery&#xD;
      following tonsillectomy Study design: A prospective double-blined randomized trial. Sample&#xD;
      size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth&#xD;
      wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be&#xD;
      treated with a placebo.&#xD;
&#xD;
      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the&#xD;
      Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for&#xD;
      tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign&#xD;
      the inform consent in one of two places: in the departments before the surgery or in the&#xD;
      clinic in the visit before the surgery. The patients will be evaluated for their ability to&#xD;
      gargle and spit water before the surgery, after which they will be assigned to either the&#xD;
      treatment group who will get a solution of Tantum Verde or the control group who will receive&#xD;
      saline with mint flavor, both in identicle bottles. Randomization will be done using a random&#xD;
      number generator program.&#xD;
&#xD;
      The patients will be asked to gargle and spit the solution they received three times a day&#xD;
      for 30 seconds, for the following week after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain: reduction in severity based on VAS score.</measure>
    <time_frame>postoperative pain using VAS(Visual Analogue Scale) on day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain: time to complete resolution based on VAS score.</measure>
    <time_frame>postoperative pain using VAS(Visual Analogue Scale) on day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively</measure>
    <time_frame>Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding: time to complete cessation, need for re-operation</measure>
    <time_frame>bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding: postoperative measures to reduce bleeding</measure>
    <time_frame>bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission for any reason.</measure>
    <time_frame>14 Days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>day14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to normal diet and activities.</measure>
    <time_frame>day 14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Tonsillectomy</condition>
  <condition>Adenoidectomy</condition>
  <arm_group>
    <arm_group_label>Tantum Verde® mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>solution of Tantum Verde</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo mouthwash</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline with mint flavor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tantum Verde® mouthwash</intervention_name>
    <arm_group_label>Tantum Verde® mouthwash</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo mouthwash</intervention_name>
    <description>Mouthwash with placebo solution</description>
    <arm_group_label>placebo mouthwash</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing tonsillectomy with or without adenoidectomy&#xD;
&#xD;
          -  Over 12 years of age&#xD;
&#xD;
          -  Signed informed consent by patient or caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to gargle and spit&#xD;
&#xD;
          -  Allergy to one of the solution ingredients&#xD;
&#xD;
          -  Significant comorbidity (e.g. diabetes, bleeding disorders)&#xD;
&#xD;
          -  Unable/ unwilling to comply with the protocol requirements&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of entry into this study&#xD;
&#xD;
        Withdrawal Criteria:&#xD;
&#xD;
        • Patients did not comply with the protocol requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galillee medical center</name>
      <address>
        <city>Naharia</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Galilee Hospital-Nahariya</investigator_affiliation>
    <investigator_full_name>Ronen Ohad</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Patients undergoing tonsillectomy with or without adenoidectomy</keyword>
  <!-- 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/NCT02190162
org study id: 0028-14-NHR
nct id: NCT02190162
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the effects of Tantum Verde® for improving recovery
      following tonsillectomy Study design: A prospective double-blined randomized trial. Sample
      size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth
      wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be
      treated with a placebo.

      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the
      Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for
      tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign
      the inform consent in one of two places: in the departments before the surgery or in the
      clinic in the visit before the surgery. The patients will be evaluated for their ability to
      gargle and spit water before the surgery, after which they will be assigned to either the
      treatment group who will get a solution of Tantum Verde or the control group who will receive
      saline with mint flavor, both in identicle bottles. Randomization will be done using a random
      number generator program.

      The patients will be asked to gargle and spit the solution they received three times a day
      for 30 seconds, for the following week after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Pain: reduction in severity based on VAS score.
time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
measure: Pain: time to complete resolution based on VAS score.
time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
measure: Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively
time frame: Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14
measure: Bleeding: time to complete cessation, need for re-operation
time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
measure: Bleeding: postoperative measures to reduce bleeding
time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
measure: Readmission for any reason.
time frame: 14 Days after surgery
measure: Duration of hospital stay
time frame: day14
measure: Time to return to normal diet and activities.
time frame: day 14
arm group label: Tantum Verde® mouthwash
arm group type: Active Comparator
description: solution of Tantum Verde
arm group label: placebo mouthwash
arm group type: Placebo Comparator
description: saline with mint flavor
intervention type: Drug
intervention name: Tantum Verde® mouthwash
arm group label: Tantum Verde® mouthwash
intervention type: Other
intervention name: Placebo mouthwash
description: Mouthwash with placebo solution
arm group label: placebo mouthwash
criteria: 
gender: All
minimum age: 12 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Western Galilee Hospital-Nahariya
investigator full name: Ronen Ohad
investigator title: MD