Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Chronic Sinus Infection Clinical Trial

Official title:

Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03369717
• Other study ID #: 2017-8460
• Status: Suspended
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: July 2023

Study information

• Verified date: February 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Sinus Infection
• Sinusitis

Intervention

Drug:
• Amoxi Clavulanate
Postoperative antibiotics

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in postoperative infection		8 weeks
Primary	Improvement in postoperative endoscopy scores		8 weeks
Primary	Improvement in postoperative SNOT-22 scores		8 weeks