Status:
TERMINATED
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Mount Sinai Hospital, New York
NYU Langone Health
Conditions:
Chronic Sinus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional...
Eligibility Criteria
Inclusion
- Patients with Chronic Rhinosinusitis (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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03369717
Start Date
August 1 2018
End Date
May 7 2020
Last Update
June 17 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467