RecruitingACTRN12619000117112

Comparing post-sinus surgery symptoms of chronic sinusitis patients using Flo Sinus Care or Flo Kappa sinus rinses

Double blinded randomised controlled clinical trial comparing Flo Sinus Care with Flo Sinus Care containing carrageenan (Flo Kappa) for the management of symptoms in the immediate post-operative period in chronic sinusitis patients who have undergone sinus surgery

Sponsor

Associate Professor Alkis Psaltis

Enrollment

50 participants

Start Date

Jun 18, 2020

Study Type

Interventional

Conditions

Chronic rhinosinusitis

Summary

To determine whether adding kappa carrageenan to over-the-counter sinus rinse Flo Sinus Care can hasten the recovery after surgery when compared to the product alone. 50 participants will be recruited from The Queen Elizabeth Hospital who require endoscopic sinus surgery to treat chronic rhinosinusitis. Their randomised blinded treatment will be either Flo Sinus Care or Flo Kappa sachets for reconstitution and delivered as a sinus rinse for 12 weeks following surgery. We will assess each patient at time of surgery, 2 weeks, 6-8 weeks, and 3 months post-surgery using endoscopic scores and symptom scores, as well as an. intranasal bacterial swab and mucus sample at each time-point to measure inflammatory cytokines. Following on from our in vitro work with the above-mentioned treatments, we expect Flo Kappa to have a positive effect on healing and patient symptoms by way of reduced infection and inflammation.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic rhinosinusitis — long-standing inflammation of the sinuses — often requires surgery when medications fail. After surgery, the sinuses need time to heal, and infections or inflammation can slow this process. This study adds a special ingredient called kappa carrageenan (derived from seaweed) to an over-the-counter sinus rinse (Flo Sinus Care) and tests whether it helps the sinuses heal faster and reduces symptoms after surgery. Fifty participants who are having endoscopic sinus surgery for chronic rhinosinusitis are randomly assigned to rinse their sinuses twice daily for 12 weeks after surgery with either the carrageenan-enhanced rinse (Flo Kappa) or the standard Flo Sinus Care rinse. Outcomes — including endoscopic scores, symptom scores, bacterial swabs, and inflammatory markers — are measured at surgery, 2 weeks, 6-8 weeks, and 3 months after surgery. You may be eligible if you are over 18, have a medical diagnosis of chronic rhinosinusitis that has not responded to treatment, are scheduled for bilateral frontosphenoethmoidectomy (a standard type of sinus surgery), and have a healthy immune system. You are not eligible if you are under 18, pregnant or breastfeeding, immunocompromised, or allergic to carrageenan.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Comparing the immediate post-operative outcomes of patients after sinus surgery when they rinse with Flo Kappa sinus rinse kit, compared to the standard of care rinse kit (Flo Sinus Care). The stud

Comparing the immediate post-operative outcomes of patients after sinus surgery when they rinse with Flo Kappa sinus rinse kit, compared to the standard of care rinse kit (Flo Sinus Care). The study will have two randomised double-blinded arms: Control (standard of care rinse Flo Sinus Care), n=25 Flo Kappa rinse, n=25 After sinus surgery, patients will be randomly allocated standard of care sinus rinse kit (Flo Sinus Care) or modified rinse kit containing seaweed extract, kappa carrageenan (Flo Kappa). The kits consist of a clear plastic rinse bottle with nozzle and 1.9g powder sachets for reconstitution in 200mL boiled tepid water. Once reconstituted, the solution consists of sodium chloride (0.772%w/v), potassium chloride (0.042%w/v), calcium lactate pentahydrate (0.032%w/v), sodium bicarbonate (0.015%w/v), glucose anhydrous (0.085%w/v), and kappa carrageenan (0.12%w/v). This closely resembles Lactated Ringer's solution (plus kappa carrageenan). Isotonic pH of 7.2-8.0. No other chemicals or preservatives. The participant will mix one sachet per one 200mL rinse bottle, and douche with one bottle (and one sachet) per side of the nose. Hence be using two bottles (and two sachets) per nasal rinse. This is repeated 4 times per day (i.e. 8 rinse bottle and 8 sachets per day) for the first 2 weeks, then 2 times per day (4 rinse bottles and 4 sachets per day) for another 10 weeks. The washing schedule will run for 12 weeks total. The kit and sachets will be provided to the participant upon discharge from the hospital, with instructions for use. Neither the PI, follow-up doctors, or trial coordinators will know which sachets the participant is given, the treatments will be blinded by Pharmacy. The participant is given verbal and written instruction on the intervention mode and frequency upon consent to the trial. Their adherence to the rinsing schedule will be checked at post-op visit 2 weeks, 6-8 weeks and 3 months (exit visit) by a Trial Coordinator. A Trial Coordinator will accompany the patient to these post-op visits, when they see their ENT doctor. During these standard of care appointments, questionnaire, a nasal swab and a mucus sample is collected along with sinus endoscopic score. Adverse side events and concomitant medications are also checked at each appointment.