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

Chronic Rhinosinusitis Clinical Trial

Official title:

Head to Head Comparison of Chitodex Gel With Triamcinolone vs NexFoam With Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083741
• Other study ID #: 31454
• Status: Recruiting
• Start date: December 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: St. Louis University
• Contact: Otolaryngology Research Division
• Phone: 314-977-8884
• Email: oto-research[@]slu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 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

2. = 18 years to = 90 years AND

3. English speaking AND

4. Able to give written informed consent AND

5. Local residents who will be returning to this center for postoperative follow-up care AND

6. Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op.

Exclusion Criteria:

1. allergy to shellfish

2. pregnant or breastfeeding

3. Hepatitis or blood disorders

4. any drug allergy

5. allergy to potato starch (due to Nexfoam)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Device:
• Chitogel
post-operative dressing within standard of care
• Nexfoam
post-operative dressing within standard of care

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Scores on Endoscopy	Outcome measured based on the wound healing in the sinus openings made during surgery.	12 (±2) weeks post surgery
Secondary	Symptom Scores on Patients' Self-Directed Questionnaires	Outcomes measured based on patients' personal symptom assessment.	12 (±2) weeks post surgery