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Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients

This study is not yet open for participant recruitment.
Verified November 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT03303677
First Posted: October 6, 2017
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery.

Condition Intervention Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Saline Nasal Drug: Budesonide Nasal Drug: Topical Antibacterial (Product) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization into one of three treatment arms
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Post op Outcomes in Endoscopic Sinus Surgery Using Varying Nasal Sinus Irrigations. Saline vs. Saline and Budesonide vs Saline, Budesonide, and Culture Directed Topical Antibiotics

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys [ Time Frame: Up to 12 weeks post op ]
    The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.

  • Change in symptom scores on Rhinosinusitis Disability Index (RSDI) [ Time Frame: Up to 12 weeks post op ]
    The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.

  • Nasal endoscopy findings [ Time Frame: Up to 12 weeks post op ]
    Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found


Estimated Enrollment: 55
Anticipated Study Start Date: January 1, 2018
Estimated Study Completion Date: November 1, 2019
Estimated Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saline
Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Drug: Saline Nasal
topical nasal saline rinses
Experimental: Saline and budesonide
Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Drug: Saline Nasal
topical nasal saline rinses
Drug: Budesonide Nasal
saline + budesonide nasal saline irrigation
Experimental: saline, budesonide, and topical antibiotic
Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.
Drug: Saline Nasal
topical nasal saline rinses
Drug: Budesonide Nasal
saline + budesonide nasal saline irrigation
Drug: Topical Antibacterial (Product)
The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
Other Name: Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and radiographic criteria who are undergoing endoscopic sinus surgery

Exclusion Criteria:

  • Age <18
  • endoscopic sinus surgery for reason other than CRS
  Contacts and Locations
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): NCT03303677


Contacts
Contact: Stewart Bernard, MD (352) 273-5199 stewart.bernard@ent.ufl.edu

Locations
United States, Florida
Univeristy of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Jeb Justice, MD University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03303677     History of Changes
Other Study ID Numbers: IRB201701952
First Submitted: September 26, 2017
First Posted: October 6, 2017
Last Update Posted: November 16, 2017
Last Verified: November 2017
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 University of Florida:
endoscopic sinus surgery
topical nasal therapy

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Ciprofloxacin
Gentamicins
Mupirocin
Levofloxacin
Ofloxacin
Antibiotics, Antitubercular
Budesonide
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Antitubercular Agents
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids