<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/NCT03014687</url>
  </required_header>
  <id_info>
    <org_study_id>PHX-16-0134-30-12</org_study_id>
    <nct_id>NCT03014687</nct_id>
  </id_info>
  <brief_title>Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions</brief_title>
  <acronym>POET</acronym>
  <official_title>A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Hospital and Medical Center, Phoenix</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Joseph's Hospital and Medical Center, Phoenix</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for&#xD;
      pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection&#xD;
      (sinusitis), and helps mucosal healing in the nasal passages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas.&#xD;
      Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and&#xD;
      pituitary gland, the technique causes disruption of sinonasal function and temporarily&#xD;
      impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of&#xD;
      postoperative morbidity following transsphenoidal surgery. Common sinonasal complications&#xD;
      include sinusitis, synechiae formation, nasal obstruction and crusting. The development of&#xD;
      postoperative sinusitis is specifically associated with decreased sinonasal function after&#xD;
      surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely&#xD;
      prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard&#xD;
      prophylactic perioperative intravenous antibiotics) with the intention of improving nasal&#xD;
      functional outcomes. To date, no studies have examined whether the administration of oral&#xD;
      antibiotics following transsphenoidal surgery improves sinonasal healing. This question has&#xD;
      been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A&#xD;
      meta-analysis of clinical trial data obtained in FESS indicated that current literature does&#xD;
      not support the use of oral antibiotics to reduce infection, improve symptoms scores, or&#xD;
      improve endoscopic findings. Furthermore, there is the potential for antibiotic-related&#xD;
      adverse events including the emergence of bacterial resistance, Clostridium difficile&#xD;
      infection, and allergic reactions to the medication. Despite the lack of supporting evidence&#xD;
      in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in&#xD;
      pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics&#xD;
      following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis&#xD;
      incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Acute Bacterial Sinusitis</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)</measure>
    <time_frame>1-2 and 3-4 weeks post-surgery</time_frame>
    <description>Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinusitis and antibiotic resistance as evidenced by nasal congestion</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Cultures and sensitivities when nasal congestion noted by patient report or physical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinusitis and antibiotic resistance as evidenced by purulent discharge</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinusitis and antibiotic resistance as evidenced by pressure</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Cultures and sensitivities when facial pressure noted by patient report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinusitis and antibiotic resistance as evidenced by pain</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Cultures and sensitivities when facial pain noted by patient report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinusitis and antibiotic resistance as evidenced headache</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery</time_frame>
    <description>Cultures and sensitivities when headache noted by patient report.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Antibiotics</condition>
  <condition>Pituitary Adenoma</condition>
  <arm_group>
    <arm_group_label>Standard Nasal Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Nasal Care + Oral Antibiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.</description>
    <arm_group_label>Standard Nasal Care</arm_group_label>
    <other_name>inert substance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole</intervention_name>
    <description>Oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.</description>
    <arm_group_label>Standard Nasal Care + Oral Antibiotics</arm_group_label>
    <other_name>Omnicef</other_name>
    <other_name>Bactrim DS™ cephalosporin intolerant patients</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient undergoing endoscopic surgery for resection of pituitary tumors for&#xD;
             nonfunctioning adenoma, acromegaly, or prolactinoma&#xD;
&#xD;
          -  Adults &gt;18 and &lt;85 years of age&#xD;
&#xD;
          -  English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales&#xD;
&#xD;
          -  Free of any physical, mental, or medical condition which, in the opinion of the&#xD;
             investigator, makes study participation inadvisable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anaphylaxis/intolerance to the study drugs&#xD;
&#xD;
          -  Cirrhosis, hepatitis&#xD;
&#xD;
          -  Any solid organ transplant or bone marrow transplant. And any patient felt to be&#xD;
             immunocompromised by the investigators&#xD;
&#xD;
          -  Renal failure on dialysis&#xD;
&#xD;
          -  Any subject who is unwilling or unable to sign informed consent for the study&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Incarcerated patients&#xD;
&#xD;
          -  Cushing's disease&#xD;
&#xD;
          -  Rathke's Cleft cyst or pituitary cyst&#xD;
&#xD;
          -  History of chronic sinusitis&#xD;
&#xD;
          -  Anticipated use of nasal splints&#xD;
&#xD;
          -  Anticipated use of nasal septal flap&#xD;
&#xD;
          -  Active sinusitis&#xD;
&#xD;
          -  Nasal polyps&#xD;
&#xD;
          -  Previous sinus surgery&#xD;
&#xD;
          -  Concurrent antibiotics for another indication (i.e., urinary tract infection)&#xD;
&#xD;
          -  Immunodeficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Little, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Barrow Brain and Spine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Evans, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heidi Jahnke, RN, MSN</last_name>
    <phone>602-406-6976</phone>
    <email>heidi.jahnke@dignityhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Barrow Brain and Spine</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heidi Jahnke, RN,MSN</last_name>
      <phone>602-406-6976</phone>
      <email>heidi.jahnke@dignityhealth.org</email>
    </contact>
    <investigator>
      <last_name>Andrew Little, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Evans, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Varun Kshettry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Hospital and Medical Center, Phoenix</investigator_affiliation>
    <investigator_full_name>Pam Dewey</investigator_full_name>
    <investigator_title>Research Manager</investigator_title>
  </responsible_party>
  <keyword>transsphenoidal surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Pituitary Neoplasms</mesh_term>
    <mesh_term>Pituitary Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Cefdinir</mesh_term>
    <mesh_term>Cephalosporins</mesh_term>
    <mesh_term>Trimethoprim</mesh_term>
    <mesh_term>Sulfamethoxazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 5, 2021</submitted>
    <returned>November 2, 2021</returned>
  </pending_results>
  <!-- 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/NCT03014687
org study id: PHX-16-0134-30-12
nct id: NCT03014687
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for
      pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection
      (sinusitis), and helps mucosal healing in the nasal passages.
Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas.
      Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and
      pituitary gland, the technique causes disruption of sinonasal function and temporarily
      impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of
      postoperative morbidity following transsphenoidal surgery. Common sinonasal complications
      include sinusitis, synechiae formation, nasal obstruction and crusting. The development of
      postoperative sinusitis is specifically associated with decreased sinonasal function after
      surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely
      prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard
      prophylactic perioperative intravenous antibiotics) with the intention of improving nasal
      functional outcomes. To date, no studies have examined whether the administration of oral
      antibiotics following transsphenoidal surgery improves sinonasal healing. This question has
      been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A
      meta-analysis of clinical trial data obtained in FESS indicated that current literature does
      not support the use of oral antibiotics to reduce infection, improve symptoms scores, or
      improve endoscopic findings. Furthermore, there is the potential for antibiotic-related
      adverse events including the emergence of bacterial resistance, Clostridium difficile
      infection, and allergic reactions to the medication. Despite the lack of supporting evidence
      in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in
      pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics
      following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis
      incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.
measure: Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.
measure: Incidence of Acute Bacterial Sinusitis
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.
measure: Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)
time frame: 1-2 and 3-4 weeks post-surgery
description: Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.
measure: Sinusitis and antibiotic resistance as evidenced by nasal congestion
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Cultures and sensitivities when nasal congestion noted by patient report or physical exam.
measure: Sinusitis and antibiotic resistance as evidenced by purulent discharge
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.
measure: Sinusitis and antibiotic resistance as evidenced by pressure
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Cultures and sensitivities when facial pressure noted by patient report.
measure: Sinusitis and antibiotic resistance as evidenced by pain
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Cultures and sensitivities when facial pain noted by patient report.
measure: Sinusitis and antibiotic resistance as evidenced headache
time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
description: Cultures and sensitivities when headache noted by patient report.
arm group label: Standard Nasal Care
arm group type: Placebo Comparator
description: One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.
arm group label: Standard Nasal Care + Oral Antibiotics
arm group type: Experimental
description: One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.
intervention type: Drug
intervention name: Placebo
description: PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
arm group label: Standard Nasal Care
other name: inert substance
intervention type: Drug
intervention name: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
description: Oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
arm group label: Standard Nasal Care + Oral Antibiotics
other name: Omnicef
other name: Bactrim DS™ cephalosporin intolerant patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Andrew Little, MD
role: Study Chair
affiliation: Barrow Brain and Spine
last name: James Evans, MD
role: Study Chair
affiliation: Thomas Jefferson University
last name: Heidi Jahnke, RN, MSN
phone: 602-406-6976
email: heidi.jahnke@dignityhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Hospital and Medical Center, Phoenix
investigator full name: Pam Dewey
investigator title: Research Manager
mesh term: Adenoma
mesh term: Pituitary Neoplasms
mesh term: Pituitary Diseases
mesh term: Anti-Bacterial Agents
mesh term: Cefdinir
mesh term: Cephalosporins
mesh term: Trimethoprim
mesh term: Sulfamethoxazole
sharing ipd: Undecided
submitted: October 5, 2021
returned: November 2, 2021