Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Phase 4

Suspended

• Conditions: Chronic Sinus Infection
• Interventions: Drug: Amoxi Clavulanate

• Registration Number: NCT03369717
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Study Start: 2018-08-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07
• Primary Completion: 2023-01
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics	Amoxi Clavulanate	To receive postoperative antibiotics

Primary Outcome Measures

Name	Time	Method
Improvement in postoperative SNOT-22 scores	8 weeks
Decrease in postoperative infection	8 weeks
Improvement in postoperative endoscopy scores	8 weeks

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States