Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

M

Montefiore Medicine Academic Health System

Status and phase

Suspended
Phase 4

Conditions

Chronic Sinus Infection

Treatments

Drug: Amoxi Clavulanate

Study type

Interventional

Funder types

Other

Identifiers

NCT03369717
2017-8460

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

400 participants in 2 patient groups

Antibiotics
Experimental group
Description:
To receive postoperative antibiotics
Treatment:
Drug: Amoxi Clavulanate
No antibiotics
No Intervention group
Description:
Will not receive any postoperative antibiotics

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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