<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/NCT03303677</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701952</org_study_id>
    <nct_id>NCT03303677</nct_id>
  </id_info>
  <brief_title>Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients</brief_title>
  <official_title>Comparison of Post op Outcomes in Endoscopic Sinus Surgery Using Varying Nasal Sinus Irrigations. Saline vs. Saline and Budesonide vs Saline, Budesonide, and Culture Directed Topical Antibiotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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 study is to compare postoperative symptom scores and endoscopy findings&#xD;
      between in patients who receive either nasal saline rinses, saline + budesonide, and saline +&#xD;
      topical antibiotics and budesonide following endoscopic sinus surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The group of patients from which the study tem will recruit consists of patients referred to&#xD;
      the University of Florida tertiary referral rhinology practice of Dr. Jeb Justice and Dr.&#xD;
      William Collins. Patients with CRS defined by symptom, endoscopic, and radiographic criteria&#xD;
      who are candidates for surgical intervention will be identified by the above-mentioned&#xD;
      investigators. As part of their initial pre operative work up they will be asked to fill out&#xD;
      SNOT-22 and RSDI surveys. As part of their surgery intraoperative cultures will be obtained&#xD;
      from the surgically opened sinus cavities. The above radiologic, endoscopic procedures,&#xD;
      cultures and QOL/symptoms surveys are typical in the workup of patients who present with&#xD;
      rhinologic related problems. None of the above tests will be undertaken for the sole purpose&#xD;
      of this study.&#xD;
&#xD;
      If the patient meets criteria, he/she will be approached by one of the investigators about&#xD;
      participating in the research study. Information regarding the study, including the informed&#xD;
      consent form, will be extensively discussed. If the patient agrees to take part in this&#xD;
      study, the consent form will be provided for review and will then be signed. This consent&#xD;
      form will be kept in a secure locked location with access given only to study staff&#xD;
      identified in the Institutional Review Board (IRB) protocol. It will be explained to the&#xD;
      patients that there is no obligation for them to participate in the study and that they can&#xD;
      drop out of the study at any time without repercussions regarding their care.&#xD;
&#xD;
      If a patient elects to be a part of the study they will be randomized into one of three&#xD;
      treatment arms. This process will be done by placing an equal number of note cards in&#xD;
      envelopes. The note cards will contain either a &quot;1&quot;, &quot;2&quot;, or &quot;3&quot; to represent the different&#xD;
      treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the&#xD;
      otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn&#xD;
      and it is documented which treatment arm the patient will be treated under.&#xD;
&#xD;
      All patients will begin with normal saline irrigations immediately following surgery as per&#xD;
      our department's standard of care. At their first one week post op appointment they will then&#xD;
      begin treatment per the treatment arm. The first treatment arm will consist of patients that&#xD;
      are given only saline nasal irrigations to be performed twice daily. The second arm will be&#xD;
      given a prescription for nasal saline + budesonide to be performed twice daily. The final arm&#xD;
      will be given a prescription for nasal saline + budesonide + a culture directed topical&#xD;
      antibiotic. These treatments are commonly used in our practice and will be obtained through&#xD;
      the compounding pharmacies that are already in use by our practice.&#xD;
&#xD;
      Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up&#xD;
      appointments. At each of these appointments they will undergo nasal endoscopy and debridement&#xD;
      as is standard following endoscopic sinus surgery. They will also be asked to fill out&#xD;
      SNOT-22 and RSDI surveys to monitor their progression.&#xD;
&#xD;
      The RSDI contains 30 questions designed to measure the patient's disease-specific status in&#xD;
      the physical, emotional, and functional domains. The questions present the patient with&#xD;
      symptoms and ask if there experience the symptoms never, almost never, sometimes, almost&#xD;
      always, and always. These are scored as 0-4, with never getting a score of 0 and always&#xD;
      getting a score of 4 for a total score range of 0-120.&#xD;
&#xD;
      The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5&#xD;
      where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it&#xD;
      possibly can be. The Snot-22 has a cumulative score of 0-110.&#xD;
&#xD;
      Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This&#xD;
      system grades the endoscopic findings within the paranasal sinuses for the presence of:&#xD;
      polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored&#xD;
      separately and then combined for the total score. Polyps are scored as absent (0), present in&#xD;
      middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0),&#xD;
      thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately&#xD;
      as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal&#xD;
      cavity a total score from 0-20 is found.&#xD;
&#xD;
      Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy&#xD;
      findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.&#xD;
&#xD;
      Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard&#xD;
      practice. During treatment patients will be treated as per standard which could include the&#xD;
      use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition&#xD;
      warrants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn by sponsor&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 1, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2018</primary_completion_date>
  <phase>Phase 3</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>Randomization into one of three treatment arms</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys</measure>
    <time_frame>Up to 12 weeks post op</time_frame>
    <description>The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in symptom scores on Rhinosinusitis Disability Index (RSDI)</measure>
    <time_frame>Up to 12 weeks post op</time_frame>
    <description>The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nasal endoscopy findings</measure>
    <time_frame>Up to 12 weeks post op</time_frame>
    <description>Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Rhinosinusitis (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline and budesonide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline, budesonide, and topical antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Nasal</intervention_name>
    <description>topical nasal saline rinses</description>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_label>Saline and budesonide</arm_group_label>
    <arm_group_label>saline, budesonide, and topical antibiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide Nasal</intervention_name>
    <description>saline + budesonide nasal saline irrigation</description>
    <arm_group_label>Saline and budesonide</arm_group_label>
    <arm_group_label>saline, budesonide, and topical antibiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Antibacterial (Product)</intervention_name>
    <description>The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole</description>
    <arm_group_label>saline, budesonide, and topical antibiotic</arm_group_label>
    <other_name>Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and&#xD;
             radiographic criteria who are undergoing endoscopic sinus surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  endoscopic sinus surgery for reason other than CRS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeb Justice, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.</citation>
    <PMID>25832968</PMID>
  </results_reference>
  <results_reference>
    <citation>Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.</citation>
    <PMID>26363164</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.</citation>
    <PMID>28124652</PMID>
  </results_reference>
  <results_reference>
    <citation>Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.</citation>
    <PMID>18702902</PMID>
  </results_reference>
  <results_reference>
    <citation>Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.</citation>
    <PMID>22980682</PMID>
  </results_reference>
  <results_reference>
    <citation>Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.</citation>
    <PMID>22311838</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.</citation>
    <PMID>24119597</PMID>
  </results_reference>
  <results_reference>
    <citation>Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.</citation>
    <PMID>27556896</PMID>
  </results_reference>
  <results_reference>
    <citation>Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.</citation>
    <PMID>27440128</PMID>
  </results_reference>
  <results_reference>
    <citation>Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.</citation>
    <PMID>23776108</PMID>
  </results_reference>
  <results_reference>
    <citation>Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.</citation>
    <PMID>27466854</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.</citation>
    <PMID>19128645</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endoscopic sinus surgery</keyword>
  <keyword>topical nasal therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Ciprofloxacin</mesh_term>
    <mesh_term>Gentamicins</mesh_term>
    <mesh_term>Mupirocin</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Trimethoprim</mesh_term>
    <mesh_term>Sulfamethoxazole</mesh_term>
    <mesh_term>Budesonide</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/NCT03303677
org study id: IRB201701952
nct id: NCT03303677
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The goal of the study is to compare postoperative symptom scores and endoscopy findings
      between in patients who receive either nasal saline rinses, saline + budesonide, and saline +
      topical antibiotics and budesonide following endoscopic sinus surgery.
The group of patients from which the study tem will recruit consists of patients referred to
      the University of Florida tertiary referral rhinology practice of Dr. Jeb Justice and Dr.
      William Collins. Patients with CRS defined by symptom, endoscopic, and radiographic criteria
      who are candidates for surgical intervention will be identified by the above-mentioned
      investigators. As part of their initial pre operative work up they will be asked to fill out
      SNOT-22 and RSDI surveys. As part of their surgery intraoperative cultures will be obtained
      from the surgically opened sinus cavities. The above radiologic, endoscopic procedures,
      cultures and QOL/symptoms surveys are typical in the workup of patients who present with
      rhinologic related problems. None of the above tests will be undertaken for the sole purpose
      of this study.

      If the patient meets criteria, he/she will be approached by one of the investigators about
      participating in the research study. Information regarding the study, including the informed
      consent form, will be extensively discussed. If the patient agrees to take part in this
      study, the consent form will be provided for review and will then be signed. This consent
      form will be kept in a secure locked location with access given only to study staff
      identified in the Institutional Review Board (IRB) protocol. It will be explained to the
      patients that there is no obligation for them to participate in the study and that they can
      drop out of the study at any time without repercussions regarding their care.

      If a patient elects to be a part of the study they will be randomized into one of three
      treatment arms. This process will be done by placing an equal number of note cards in
      envelopes. The note cards will contain either a "1", "2", or "3" to represent the different
      treatment arms. These will be placed in the envelopes, shuffled, and kept in a box in the
      otolaryngology clinic. At the patient's first postoperative appointment an envelope is drawn
      and it is documented which treatment arm the patient will be treated under.

      All patients will begin with normal saline irrigations immediately following surgery as per
      our department's standard of care. At their first one week post op appointment they will then
      begin treatment per the treatment arm. The first treatment arm will consist of patients that
      are given only saline nasal irrigations to be performed twice daily. The second arm will be
      given a prescription for nasal saline + budesonide to be performed twice daily. The final arm
      will be given a prescription for nasal saline + budesonide + a culture directed topical
      antibiotic. These treatments are commonly used in our practice and will be obtained through
      the compounding pharmacies that are already in use by our practice.

      Patients will be seen in follow up at 1-2 week, 3-4 week, 6-8 week, and 10-12 week follow up
      appointments. At each of these appointments they will undergo nasal endoscopy and debridement
      as is standard following endoscopic sinus surgery. They will also be asked to fill out
      SNOT-22 and RSDI surveys to monitor their progression.

      The RSDI contains 30 questions designed to measure the patient's disease-specific status in
      the physical, emotional, and functional domains. The questions present the patient with
      symptoms and ask if there experience the symptoms never, almost never, sometimes, almost
      always, and always. These are scored as 0-4, with never getting a score of 0 and always
      getting a score of 4 for a total score range of 0-120.

      The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5
      where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it
      possibly can be. The Snot-22 has a cumulative score of 0-110.

      Endoscopy findings will be scored using the Lund-Kennedy endoscopy scoring system. This
      system grades the endoscopic findings within the paranasal sinuses for the presence of:
      polyps, discharge, edema, scarring and crusting . Each side of the nasal cavity is scored
      separately and then combined for the total score. Polyps are scored as absent (0), present in
      middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0),
      thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately
      as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal
      cavity a total score from 0-20 is found.

      Final data will compare the pre and postoperative SNOT-22 and RSDI surveys, endoscopy
      findings, need for oral antibiotics, and need for oral steroids for the three treatment arms.

      Cultures will be obtained for all patients during endoscopic sinus surgery as is our standard
      practice. During treatment patients will be treated as per standard which could include the
      use of oral antibiotics, oral steroids, or nasal steroid sprays as their medical condition
      warrants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization into one of three treatment arms
primary purpose: Treatment
masking: None (Open Label)
measure: Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys
time frame: Up to 12 weeks post op
description: The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.
measure: Change in symptom scores on Rhinosinusitis Disability Index (RSDI)
time frame: Up to 12 weeks post op
description: The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.
measure: Nasal endoscopy findings
time frame: Up to 12 weeks post op
description: Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found
arm group label: Saline
arm group type: Active Comparator
description: Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
arm group label: Saline and budesonide
arm group type: Experimental
description: Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
arm group label: saline, budesonide, and topical antibiotic
arm group type: Experimental
description: Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
intervention type: Drug
intervention name: Saline Nasal
description: topical nasal saline rinses
arm group label: Saline
arm group label: Saline and budesonide
arm group label: saline, budesonide, and topical antibiotic
intervention type: Drug
intervention name: Budesonide Nasal
description: saline + budesonide nasal saline irrigation
arm group label: Saline and budesonide
arm group label: saline, budesonide, and topical antibiotic
intervention type: Drug
intervention name: Topical Antibacterial (Product)
description: The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
arm group label: saline, budesonide, and topical antibiotic
other name: Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeb Justice, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
PMID: 25832968
citation: Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.
PMID: 26363164
citation: Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.
PMID: 28124652
citation: Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.
PMID: 18702902
citation: Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.
PMID: 22980682
citation: Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.
PMID: 22311838
citation: Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.
PMID: 24119597
citation: Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.
PMID: 27556896
citation: Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.
PMID: 27440128
citation: Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.
PMID: 23776108
citation: Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.
PMID: 27466854
citation: Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.
PMID: 19128645
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Chronic Disease
mesh term: Vancomycin
mesh term: Ciprofloxacin
mesh term: Gentamicins
mesh term: Mupirocin
mesh term: Anti-Bacterial Agents
mesh term: Trimethoprim
mesh term: Sulfamethoxazole
mesh term: Budesonide
sharing ipd: No