None listed
Conditions
Brief summary
in the immediate postoperative period (same night of the surgical procedure) 51 patients will be asked to use a formulation containing Hypomellose (HPMC), Xylitol, and Hyaluronic Acid (HA) as active ingredients in one nostril and a placebo spray containing 0.9% saline solution on the other. An independent researcher will randomise and label the bottles to ensure that both the participants and the investigators will be blinded as to which nasal passage is receiving the treatment nasal spray. The bottles will be identical, labelled only with an identification number and “left” or “right” to inform the patient which side to apply each nasal spray. The patient will be instructed to carry out nasal rinses with normal saline using a squeeze bottle four times per day (the standard of care in the CRS patients after FESS). After each nasal rinse, the patient should apply the nasal sprays. The patient will be asked to apply 4 doses of the corresponding nasal spray to the indicated nostril. Follow up will be conducted at 7 days, 28 days and 60 days post-operatively. Subjective symptoms such as rhinorrhea, nasal obstruction, dryness, bleeding, and crust formation will be analysed individually with a numerical rating scale ranging from 1 to 5 (1= no discomfort, 5= very severe discomfort). Three additional questions grading the patient’s experience in parameters such as discomfort with spray application, dripping and taste will be included in the questionnaire of the third and final visit.
Interventions
51 patients will be recruited. In the immediate postoperative period, patients will have one placebo nasal spray containing normal saline 0.9% to be administered to one nasal passage and one treatment nasal spray containing the formulation with active ingredients to be administered to the other. Ingredients in the treatment spray are (Active Qty/LC per spray): Sodium Hyaluronate (SH) 0.9 mg, Xylitol 7.5, Hypromellose (HPMC 2208) 0.23 mg, Potassium Sorbate 0.15 mg, Citric Acid Anhydrous 0.18 mg,
51 patients will be recruited. In the immediate postoperative period, patients will have one placebo nasal spray containing normal saline 0.9% to be administered to one nasal passage and one treatment nasal spray containing the formulation with active ingredients to be administered to the other. Ingredients in the treatment spray are (Active Qty/LC per spray): Sodium Hyaluronate (SH) 0.9 mg, Xylitol 7.5, Hypromellose (HPMC 2208) 0.23 mg, Potassium Sorbate 0.15 mg, Citric Acid Anhydrous 0.18 mg, Sodium Citrate Dihydrate 0.38, Purified Water 140.67 mg. Patients will be asked to apply 3 puffs (sprays) on each nostril 2 times a day for 60 days. The spray will be self-administered by the patient. Administration of the spray will initiate in the immediate postoperative period (the night of the day of surgery). 3 postoperative follow-ups will be made. Follow up will be conducted at 7 days, 28 days and 60 days post-operatively. These are the usual post- operative follow up times which are based on early average mucosal healing duration. These follow up times ensure that patients do not need to attend clinic more often than standard practice. Several strategies will me used to monitor adherence to intervention including: self-report diary by the patient, the patients will be asked to bring spray bottles to clinic to confirm if content has been used. If present at clinic, family members will be asked if they have observed correct usage of the nasal spray. Subjective symptoms such as rhinorrhea, nasal obstruction, dryness, bleeding, and crust formation will be analysed individually with a numerical rating scale. Postoperative changes will be analysed with a validated endoscopic score.
Sponsors
Richard Douglas
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Chronic rhinosinusitis patients undergoing FESS due to CRS as defined by the 2020 European Position Paper on Rhinosinusitis and Nasal Polyps -18 years or older -Competent to give informed consent
Exclusion criteria
-Patients with septal perforation -Pre or postoperative severe septal deviation. If a septal deviation is present, it will not be easy to discern if nasal obstruction is due to a deviated septum or to another cause such as crusting or inflammation. -Patients who have had previous FESS. Patients with recalcitrant sinus disease who need another surgery usually have a greater compromise of normal nasal physiology, reducing effectiveness of topical therapies. -Patients with other underlying disease that affects respiratory mucosa such as cystic fibrosis, primary ciliary dyskinesia, or aspirin hypersensitivity -Any known allergies or hypersensitivity to any of the components of the formulations.
Outcome results
None listed