Triamcinolone Packing Following Endoscopic Sinus Surgery

NCT04841343 | Completed FDA Drug

• 1 other identifier: 20-002080
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic sinus surgery (ESS) is a well-established treatment strategy for medically refractory chronic rhinosinusitis. Middle meatus spacers are currently used following ESS to prevent scarring, synechiae formation, and middle turbinate lateralization. A 2012 systematic review favored spacers compared to no spacers, with a follow up 2013 systematic review finding no difference between the use of absorbable and non-absorbable spacers. This review, however, noted that steroidal spacers may reduce middle meatus scarring and adhesions. More recent data has shown the effectiveness of steroid releasing middle meatus implants in preventing middle turbinate lateralization, reducing synechiae formation, and reducing revision surgery. However, these stents are costly, and may result in excess crusting postoperatively, which limits their use in some settings. Another study investigated the use of steroid-impregnated absorbable packing materials, and demonstrated the safety and utility of this method of middle meatus packing. However, a limitation to this study was overall low enrollment with only 19 total patients enrolled. The purpose of this project is to add to the existing body of evidence regarding middle meatus spacers, by studying the impact of steroid impregnated, bioabsorbable hemostatic packing (Hemopore®, Stryker) on postoperative visualization and scar formation.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Lund Kennedy Endoscopy score

  Assessment of inflammation, crusting, polyps, edema in sinus; Scale from 0 to 2, with higher scores meaning worse outcome

  1 week

Interventions

Triamcinolone DRUG

Triamcinolone in sinus

Eligibility Criteria

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

Study Population

Patients over age 18 who have bilateral chronic sinusitis who have failed previous medical therapy and will undergo endoscopic sinus surgery

You may qualify if:

• aged 18 and older
• diagnosis of chronic rhinosinusitis based on the 2016 International Consensus Statement on Allergy and Rhinology: Rhinosinusitis definition
• failed a trial of previous medical therapy
• have bilateral sinus disease on CT imaging
• will undergo bilateral endoscopic sinus surgery.

You may not qualify if:

• unable to give informed consent
• not a candidate for endoscopic sinus surgery

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Zhao X, Grewal A, Briel M, Lee JM. A systematic review of nonabsorbable, absorbable, and steroid-impregnated spacers following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Nov;3(11):896-904. doi: 10.1002/alr.21201. Epub 2013 Jul 24.

  PMID: 23894058 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 RESULT

MeSH Terms

Conditions

Sinusitis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: January 29, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)