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

December 7, 2022 updated by: Li-Xing Man, University of Rochester

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Department of Otolaryngology Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioabsorbable steroid releasing sinus implant & 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
Time Frame: 12 months
Grading by a blinded independent sinus expert as to whether the propel sinus stent frontal sinusotomy side is better, worse or the same, in terms of overall appearance after implant removal
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Adhesion/Scarring Scale - Left Side
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 - Left side
12 months
Adhesion/Scarring Scale - Right Side
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
12 months
Polypoid Edema Scale - Left Side
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
12 months
Polypoid Edema Scale - Right Side
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
12 months
Frontal Sinus Opening Size
Time Frame: 12 months
Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB 00058385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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