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Use of Perioperative Antibiotics in Endoscopic Sinus Surgery

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ClinicalTrials.gov Identifier: NCT03369717
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Nadeem Akbar, 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.

Condition or disease Intervention/treatment Phase
Chronic Sinus Infection Drug: Amoxi Clavulanate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Perioperative Antibiotics in Endoscopic Sinus Surgery
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antibiotics
To receive postoperative antibiotics
Drug: Amoxi Clavulanate
Postoperative antibiotics

No Intervention: No antibiotics
Will not receive any postoperative antibiotics



Primary Outcome Measures :
  1. Decrease in postoperative infection [ Time Frame: 8 weeks ]
  2. Improvement in postoperative endoscopy scores [ Time Frame: 8 weeks ]
  3. Improvement in postoperative SNOT-22 scores [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369717


Contacts
Contact: Nadeem A Akbar, MD 7189204646 nakbar@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Nadeem Akbar, MD Assistant Professor

Responsible Party: Nadeem Akbar, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03369717     History of Changes
Other Study ID Numbers: 2017-8460
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nadeem Akbar, Montefiore Medical Center:
endoscopic sinus surgery
antibiotics

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action