Back to resultsUse of Perioperative Antibiotics in Endoscopic Sinus Surgery
Primary Purpose
Chronic Sinus Infection
Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amoxi Clavulanate
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Sinus Infection focused on measuring endoscopic sinus surgery, antibiotics
Eligibility Criteria
Inclusion Criteria:
- Patients with CRS with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.
Exclusion Criteria:
- Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antibiotics
No antibiotics
Arm Description
To receive postoperative antibiotics
Will not receive any postoperative antibiotics
Outcomes
Primary Outcome Measures
Decrease in postoperative infection
Improvement in postoperative endoscopy scores
Improvement in postoperative SNOT-22 scores
Secondary Outcome Measures
Full Information
NCT ID
NCT03369717
First Posted
December 6, 2017
Last Updated
February 3, 2022
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03369717
Brief Title
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Official Title
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Suspended
Why Stopped
Expired IRB approval since 05/07/2020
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine whether the use of postoperative antibiotics following ESS decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinus Infection
Keywords
endoscopic sinus surgery, antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
To receive postoperative antibiotics
Arm Title
No antibiotics
Arm Type
No Intervention
Arm Description
Will not receive any postoperative antibiotics
Intervention Type
Drug
Intervention Name(s)
Amoxi Clavulanate
Intervention Description
Postoperative antibiotics
Primary Outcome Measure Information:
Title
Decrease in postoperative infection
Time Frame
8 weeks
Title
Improvement in postoperative endoscopy scores
Time Frame
8 weeks
Title
Improvement in postoperative SNOT-22 scores
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with CRS with or without nasal polyposis or allergic fungal rhinosinusitis who present to the otolaryngology clinic who have been deemed suitable for bilateral ESS, and are over the age of 18 will be included.
Exclusion Criteria:
Patients with sinonasal tumors, allergies or adverse reactions to all of the antibiotics that will be used in this study (amoxicillin-clavulanate, doxycycline, clarithromycin), immunodeficiency, cystic fibrosis, pregnancy, or diabetes with nasal polyposis (inability to receive systemic steroids) will be excluded, as will patients who lack capacity to provide informed consent. Patients undergoing active treatment for malignancy will be excluded. Patients undergoing unilateral ESS or with nonabsorbable packing placed at the time of surgery will be excluded. Patients who have been on antibiotics within 2 weeks of the surgery date will be excluded. Patients with acute on chronic sinusitis or the presence of purulence at time of surgery will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Akbar, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
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