Effects of Chitodex with steroid on patients having sinus surgery for chronic rhinosinusitis
A single-blinded randomised trial evaluating the efficacy of chitosan-dextran (Chitodex) gel with topical steroid versus PureRegen gel on post-operative outcomes in the treatment of Chronic Rhinosinusitis (CRS)
Yuresh Naidoo
31 participants
Dec 1, 2021
Interventional
Conditions
Summary
This research project compares two different absorbable nasal dressings applied directly after functional endoscopic sinus surgery for the treatment of chronic rhinosinusitis. One is chitosan-dextran (Chitodex) gel mixed with a topical steroid added and the other is the current standard of care PureRegen gel. Post-operative adhesion formation to sinus openings and wound-healing will be assessed as well as the participant's subjective and objective symptoms scores.
Eligibility
Inclusion Criteria5
- Patients with symptoms of chronic rhinosinusitis (nasal discharge, post-nasal drip, nasal obstruction, facial pain, pressure, anosmia) that have been persistent for great than 3 months AND
- 18 years of age or over AND
- Are able to give written informed consent AND
- Are indicated to undergo endoscopic sinus surgery and willing AND
- Can commit to return to clinic for 2 week, 6 week and 12 week post-operative endoscopic examination (as per standard of care)
Exclusion Criteria5
- Allergy to shellfish
- Pregnancy or breastfeeding
- Hepatitis or blood disorders
- Allergy to steroids
- COVID-19 positive
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Interventions
The intervention group will be receiving all 3 of the following treatments: Chitodex gel - Generic name: Chitosan-dextran (device) - Dose administered: 10mLs - Duration of administration: Single dose at end of endoscopic sinus surgery - Mode of administration: Topical administration onto newly widened sinus ostiums and sites of incised mucosa by surgeon - Monitoring: Empty packaging serial numbers will be documented Triamcinolone - Generic name: Triamcinolone - Dose administered: 1mLs (40mg/mL formulation) - Duration of administration: Single dose at end of endoscopic sinus surgery - Mode of administration: Topical administration (incorporated into Chitodex gel prior to administration when re-constituted by attending nurse) by surgeon - Monitoring: Empty packaging serial numbers will be documented Pulmicort nasal flushes - Generic name: Budesonide - Dose administered: 2mLs (1mg/2mLs formulation) - Duration of administration: 10 weeks, commencing from 2 week post-surgery - Mode of administration: 2mLs added to sinus rinses, once daily in self-administered rinses by patient - Monitoring: Patient self-conducted daily surveys
Locations(4)
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ACTRN12621001507875