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Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out

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ClinicalTrials.gov Identifier: NCT03534362
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Brunworth, MD, St. Louis University

Brief Summary:
Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.

Condition or disease Intervention/treatment Phase
Stent Sinusitis, Frontal Device: Nasopore Device: Propel Not Applicable

Detailed Description:

Endoscopic sinus surgery is commonly used to manage chronic inflammatory frontal sinus disease that is not adequately controlled with medical therapy alone. In recalcitrant cases, a more extensive procedure called the modified endoscopic Lothrop procedure or frontal drill-out (FDO) procedure is often performed. The frontal drill-out procedure is performed endoscopically and its goal is to create one large common cavity between the left and right frontal sinuses and nasal cavities to allow adequate drainage and communication for subsequent drug delivery through sinonasal irrigations if indicated. Failure of this procedure is most commonly the results of re-stenosis of the outflow tract due to scarring, adhesions, or progressive disease such as polyposis. One meta analysis assessing the long-term complications of frontal drillouts reported an overall failure rate to be 13.9%, defined as those individuals needing further surgery. Another clinical trial reported a failure rate for a 200-person study to be 30%.

Placing a steroid-eluding biodegradable stent into the sinonasal cavities after surgery is thought to reduce the occurrence of re-stenosis, both by physically stenting the opening and by treating resultant inflammation with corticosteroid. Propel stents are made of synthetic dissolvable polymer that contains a corticosteroid (mometasone furoate) and has been FDA-approved to stent and reduce inflammation over 30 days. Similarly, Nasopore is an FDA-approved fragmentable nasal dressing that is used as a stent. Kenalog soaking the Nasopore is thought to act as the functional equivalent of the mometasone furoate found in the Propel stent, but this use is investigational. The effect of stenting and its consequences on the outcomes of FDO specifically has also not been well studied.Recent randomized-controlled trial of Propel stent placement after frontal sinusotomy (a less extensive form of frontal sinus surgery compared to FDO procedure) showed improvement in outcomes compared to no stent placement and no major complications.There are no known randomized-controlled trials to date of propel stent placement or Nasopore-soaked Kenalog placement after FDO procedure. We wish, therefore, to perform a randomized trial to compare the efficacy and outcomes of Nasopore-soaked kenalog versus propel stenting.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind (Subject) randomized, active control study. Subjects will be randomized 1:1 using the rand function in Microsoft Excel program.
Masking: Single (Participant)
Masking Description: Patients eligible for the study and consenting to participate will be randomly assigned to one of two treatment groups: 1) Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract and 2) Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
Primary Purpose: Treatment
Official Title: Randomized Trial of Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : April 13, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Nasopore Group
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent intervention applied to the post-operative outflow tract.
Device: Nasopore
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract

Active Comparator: Propel Stent Group
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement intervention applied to the post-operative outflow tract.
Device: Propel
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.




Primary Outcome Measures :
  1. Change from Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores [ Time Frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. ]
    To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.


Secondary Outcome Measures :
  1. Surgical Postoperative Complications, Devices [ Time Frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. ]
    To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore.

  2. Surgical Postoperative Complications, Frontal Sinus Pathology [ Time Frame: After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24. ]
    To ascertain the incidence of surgical complications based on the specific frontal sinus pathology.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients able to speak and understand English
  • Patients for whom frontal drill out procedure is medically indicated

Exclusion Criteria:

  • Patients who are cognitively impaired and unable to consent
  • Patients who are not candidates for Frontal Drill out
  • Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone copolymers
  • Non-English speaking patients

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): NCT03534362


Locations
United States, Missouri
Saint Louis Universtiy
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Joe D Brunworth, MD St. Louis University
  Study Documents (Full-Text)

Documents provided by Joseph Brunworth, MD, St. Louis University:

Publications:

Responsible Party: Joseph Brunworth, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT03534362     History of Changes
Other Study ID Numbers: 28525
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
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

Keywords provided by Joseph Brunworth, MD, St. Louis University:
Propel Stent
Nasopore

Additional relevant MeSH terms:
Sinusitis
Frontal Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Mometasone Furoate
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents