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Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing

This study is currently recruiting participants.
Verified October 2017 by Li-Xing Man, University of Rochester
Sponsor:
ClinicalTrials.gov Identifier:
NCT03188822
First Posted: June 15, 2017
Last Update Posted: October 30, 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):
Li-Xing Man, University of Rochester
  Purpose
The purpose of this study is to compare how two different post-surgical treatments that both deliver steroids to the frontal sinus opening affect your healing after frontal sinus surgery.

Condition Intervention
Chronic Rhinosinusitis (Diagnosis) Device: Bioabsorbable steroid releasing sinus implant Device: Bioabsorbable nasal dressing impregnated with steroid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial of Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Steroid Releasing Implant vs. a Bioabsorbable Nasal Dressing With Added Steroid

Further study details as provided by Li-Xing Man, University of Rochester:

Primary Outcome Measures:
  • Frontal sinus appearance [ Time Frame: 12 months ]
    Odds ratio for Frontal sinus appearance with designation "better" for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid


Secondary Outcome Measures:
  • Adhesion/Scarring Scale [ Time Frame: 12 months ]
    Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement

  • Adhesion/Scarring Scale [ Time Frame: 12 months ]
    Average adhesion/scarring Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement

  • Polypoid edema scale [ Time Frame: 12 months ]
    Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable steroid releasing implant placement

  • Polypoid edema scale [ Time Frame: 12 months ]
    Average polypoid edema Likert scale score (range from 0 to 4 with higher numbers indicating worse health) for appearance of the Frontal sinus opening after bioabsorbable nasal dressing with added steroid placement

  • Frontal sinus opening size [ Time Frame: 12 months ]
    Odds ratio of frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid

  • Visualization of Frontal Sinus Roof [ Time Frame: 12 months ]
    Odds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid


Estimated Enrollment: 30
Actual Study Start Date: August 25, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioabsorbable steroid releasing sinus implant
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Device: Bioabsorbable steroid releasing sinus implant
After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
Experimental: bioabsorbable nasal dressing impregnated with steroid
Patients will undergo bilateral endoscopic sinus surgery which will include bilateral frontal sinusotomy of Draf 2a or 2b type as previously described in the literature. At the conclusion of the procedure, if the patient still meets all inclusion criteria, one frontal sinus will be randomly assigned using the envelop method to receive a bioabsorbable steroid releasing implant and the other frontal sinus will receive a bioabsorbable nasal dressing impregnated with steroid
Device: Bioabsorbable nasal dressing impregnated with steroid
After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.

Detailed Description:
This is a single center, randomized & controlled trial comparing the efficacy of the Propel mini stent or Propel contour stent vs. Nasopore impregnated with Triamcinolone Acetonide at reducing frontal sinus opening stenosis and polypoid edema after endoscopic sinus surgery in patients with chronic rhinosinusitis with polyposis. Eligible subjects who undergo standard of care bilateral frontal sinusotomy will have each frontal sinus randomly assigned to either a Propel mini or contour steroid eluding stent or a Nasopore nasal dressing impregnated with 2.5 ml of Triamcinolone Acetonide 40 mg/ml. Specific Propel stent will be chosen based on the shape of frontal sinus opening and best fit as decided by the operating Surgeon. Patients will be reassessed on approximately post-operative day 7, 14, 30, 90 days, 6 months, and 12 months at their standard of care follow-up visits. On the day 14 visit, the frontal sinus Propel stent and Nasopore will be completely removed per Standard of care. Video will be taken of the frontal sinus opening, and assessed for scarring/adhesions, presence of polypoid edema, frontal sinus patency, need for oral steroids or other interventions. Additionally, endoscopic scoring of frontal sinus by the above measures will be evaluated by 2 independent sinus surgeon reviewers. The reviewers will also be asked to rank the two frontal sinus openings as better, same or worse, compared to the opposite side
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 and older
  • Diagnosis of chronic rhinosinusitis with nasal polyps based on the American Academy of Otolaryngology-Head and Neck Surgery guidelines
  • Patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral frontal sinus disease based on Computed Tomography (Lund-Mackay score greater than or equal to 1)
  • At the time of surgery bilateral frontal sinusotomy of type Draf 2a or 2b was performed using the same technique on both sides
  • Bilateral endoscopic sinus surgery performed successfully without complication
  • Frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction easily passed into frontal sinus)

Exclusion Criteria:

  • Any patient who had frontal sinus surgery for tumor
  • Allergy to mometesone and/or triamcinolone
  • Frontal sinusotomy type Draf 1 or Draf 3 performed
  • One or both frontal sinus openings not amenable to implant placement
  • Patients with chronic oral steroid dependent conditions
  • Invasive fungal sinusitis
  • Immune deficiency
  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): NCT03188822


Contacts
Contact: Carrie Dykes, PhD (585) 275-0653 carrie_dykes@urmc.rochester.edu

Locations
United States, New York
University of Rochester Department of Otolaryngology Head and Neck Surgery Recruiting
Rochester, New York, United States, 14642
Contact: Paul Allen, PhD       Paul_Allen@URMC.Rochester.edu   
Principal Investigator: Li-Xing Man, MSc, MD, MPA         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Li-Xing Man, MSc, MD, MPA University of Rochester
  More Information

Publications:

Responsible Party: Li-Xing Man, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03188822     History of Changes
Other Study ID Numbers: RSRB 00058385
First Submitted: June 13, 2017
First Posted: June 15, 2017
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes