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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03188822
• Other study ID #: RSRB 00058385
• Status: Terminated
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: November 2, 2021

Study information

• Verified date: December 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Department of Otolaryngology Head and Neck Surgery	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (11)

Chandra RK, Palmer JN, Tangsujarittham T, Kennedy DW. Factors associated with failure of frontal sinusotomy in the early follow-up period. Otolaryngol Head Neck Surg. 2004 Oct;131(4):514-8. doi: 10.1016/j.otohns.2004.03.022. — View 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. — View Citation

DeConde AS, Smith TL. Outcomes After Frontal Sinus Surgery: An Evidence-Based Review. Otolaryngol Clin North Am. 2016 Aug;49(4):1019-33. doi: 10.1016/j.otc.2016.03.024. — View Citation

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000. — View 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;(6):CD010436. doi: 10.1002/14651858.CD010436.pub2. — View Citation

Ragab SM, Lund VJ, Scadding G, Saleh HA, Khalifa MA. Impact of chronic rhinosinusitis therapy on quality of life: a prospective randomized controlled trial. Rhinology. 2010 Sep 1;48(3):305-11. doi: 10.4193/Rhin08.137. — View Citation

Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097. — View Citation

Rowe-Jones JM, Medcalf M, Durham SR, Richards DH, Mackay IS. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray. Rhinology. 2005 Mar;43(1):2-10. — View 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. Erratum In: Laryngoscope. 2020 Mar;130(3):836. — View 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. — View Citation

Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Whose Propel Sinus Stent Appeared Worse, the Same, or Better Than the Bioabsorbable Nasal Dressing	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	Adhesion/Scarring Scale - Left Side	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
Secondary	Adhesion/Scarring Scale - Right Side	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
Secondary	Polypoid Edema Scale - Left Side	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
Secondary	Polypoid Edema Scale - Right Side	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
Secondary	Frontal Sinus Opening Size	Frontal sinus opening greater than or equal to 4 mm for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid	12 months
Secondary	Visualization of Frontal Sinus Roof	Odds ratio of frontal sinus roof visualized for bioabsorbable steroid releasing implant vs. bioabsorbable nasal dressing with added steroid	12 months