Clinical trial NCT05083741: Comparison of Chitodex Gel Vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Rhinosinusitis
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SLUCare Otolaryngology Clinic

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinical Scores on Endoscopy
timeFrame: 12 (±2) weeks post surgery
Secondary outcomes:
measure: Symptom Scores on Patients' Self-Directed Questionnaires
timeFrame: 12 (±2) weeks post surgery
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Department of Otolaryngology-Head & Neck Surgery
name: Joseph D Brunworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.