None listed
Conditions
Brief 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.
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
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
Sponsors
Yuresh Naidoo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. 18 years of age or over AND 3. Are able to give written informed consent AND 4. Are indicated to undergo endoscopic sinus surgery and willing AND 5. Can commit to return to clinic for 2 week, 6 week and 12 week post-operative endoscopic examination (as per standard of care)
Exclusion criteria
1. Allergy to shellfish 2. Pregnancy or breastfeeding 3. Hepatitis or blood disorders 4. Allergy to steroids 5. COVID-19 positive
Outcome results
None listed