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

NCT03188822 | Terminated Results FDA Device

• 1 other identifier: RSRB 00058385
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adhesion/Scarring Scale - Left Side

  12 months

• Adhesion/Scarring Scale - Right Side

  12 months

• Polypoid Edema Scale - Left Side

  12 months

• Polypoid Edema Scale - Right Side

  12 months

• Frontal Sinus Opening Size

  12 months

Study Arms (1)

Bioabsorbable steroid releasing sinus implant & nasal dressing impregnated with steroid

EXPERIMENTAL

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; Device: Bioabsorbable nasal dressing impregnated with steroid

Interventions

Bioabsorbable steroid releasing sinus implant DEVICE

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 steroid releasing sinus implant & nasal dressing impregnated with steroid

Bioabsorbable nasal dressing impregnated with steroid DEVICE

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.

Bioabsorbable steroid releasing sinus implant & nasal dressing impregnated with steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, 14642, United States

Location

Related Publications (11)

• 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.

  PMID: 25832968 BACKGROUND

• 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.

  PMID: 22469599 BACKGROUND

• 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.

  PMID: 21038021 BACKGROUND

• 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.

  PMID: 15467628 BACKGROUND

• 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.

  PMID: 24616299 BACKGROUND

• 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.

  PMID: 27450618 BACKGROUND

• 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.

  PMID: 15844495 BACKGROUND

• 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.

  PMID: 18075447 BACKGROUND

• 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.

  PMID: 26068957 BACKGROUND

• 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.

  PMID: 20513050 BACKGROUND

• 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.

  PMID: 27363723 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Program Manager
• Organization: UR Medicine Otolaryngology

paul_allen@urmc.rochester.edu

5852751186

Study Officials

• Li-Xing Man, MSc, MD, MPA

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: August 25, 2017
• Primary Completion: September 28, 2021
• Study Completion: November 2, 2021
• Last Updated: January 5, 2023
• Results First Posted: December 3, 2021

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)