Comparison of Chitodex Gel Vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

NCT05083741 | Terminated DMC FDA Device

• 1 other identifier: 31454
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Clinical Scores on Endoscopy

  Outcome measured based on the wound healing in the sinus openings made during surgery.

  12 (±2) weeks post surgery

Secondary Outcomes (1)

• Symptom Scores on Patients' Self-Directed Questionnaires

  12 (±2) weeks post surgery

Study Arms (2)

Chitogel

Chitodex gel plus Kenalog inserted into the middle meatus

Device: Chitogel

Nexfoam

NexFoam plus Kenalog inserted into the middle meatus

Device: Nexfoam

Interventions

Chitogel DEVICE

post-operative dressing within standard of care

Chitogel

Nexfoam DEVICE

post-operative dressing within standard of care

Nexfoam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SLUCare Otolaryngology Clinic

You may qualify if:

• Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
• ≥ 18 years to ≤ 90 years AND
• English speaking AND
• Able to give written informed consent AND
• Local residents who will be returning to this center for postoperative follow-up care AND
• Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 \& 12 (± 2) weeks post-op.

You may not qualify if:

• allergy to shellfish
• pregnant or breastfeeding
• Hepatitis or blood disorders
• any drug allergy
• allergy to potato starch (due to Nexfoam)

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Related Publications (3)

• Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.

  PMID: 23322408 BACKGROUND

• Le T, Psaltis A, Tan LW, Wormald PJ. The efficacy of topical antibiofilm agents in a sheep model of rhinosinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):560-7. doi: 10.2500/ajr.2008.22.3232.

  PMID: 19178792 BACKGROUND

• Jervis-Bardy J, Boase S, Psaltis A, Foreman A, Wormald PJ. A randomized trial of mupirocin sinonasal rinses versus saline in surgically recalcitrant staphylococcal chronic rhinosinusitis. Laryngoscope. 2012 Oct;122(10):2148-53. doi: 10.1002/lary.23486. Epub 2012 Aug 2.

  PMID: 22865576 BACKGROUND

Study Officials

• Joseph D Brunworth, MD

  Department of Otolaryngology-Head & Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: December 27, 2021
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

US (1)