Clinical trial NCT03188822: Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing
timeFrame: 12 months
Secondary outcomes:
measure: Adhesion/Scarring Scale - Left Side
timeFrame: 12 months
measure: Adhesion/Scarring Scale - Right Side
timeFrame: 12 months
measure: Polypoid Edema Scale - Left Side
timeFrame: 12 months
measure: Polypoid Edema Scale - Right Side
timeFrame: 12 months
measure: Frontal Sinus Opening Size
timeFrame: 12 months
measure: Visualization of Frontal Sinus Roof
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Otolaryngology Head and Neck Surgery
state: New York
Study officials:
affiliation: University of Rochester
name: Li-Xing Man, MSc, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Valdes CJ, Bogado M, Samaha M. Causes of failure in endoscopic frontal sinus surgery in chronic rhinosinusitis patients. Int Forum Allergy Rhinol. 2014 Jun;4(6):502-6. doi: 10.1002/alr.21307. Epub 2014 Mar 10.
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citation: Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015 Jun 10;2015(6):CD010436. doi: 10.1002/14651858.CD010436.pub2.
citation: Cote DW, Wright ED. Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. Laryngoscope. 2010 Jun;120(6):1269-73. doi: 10.1002/lary.20905.
citation: Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.