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Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

NCT03369717 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-17

Study results available
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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 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.

Conditions

  • Chronic Sinus Infection

Interventions

DRUG

Amoxi Clavulanate

Postoperative antibiotics

Sponsors & Collaborators

  • Mount Sinai Hospital, New York

    collaborator OTHER

  • NYU Langone Health

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Nadeem Akbar, MD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-05-07
Completion
2020-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369717 on ClinicalTrials.gov