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

Not Applicable

Recruiting

• Conditions: Chronic rhinosinusitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases; Surgery - Other surgery; Infection - Other infectious diseases

• Registration Number: ACTRN12619000117112
• Lead Sponsor: Associate Professor Alkis Psaltis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Over 18 years old, a medical diagnosis of chronic rhinosinusitis (CRS) which is unresponsive to treatment and now requires surgery, procedure scheduled is a bilateral frontosphenoethmoidectomy (FH-FESS), immunocompetent.

Exclusion Criteria

under 18 years old, pregnant, breastfeeding, immunocompromised, immunosuppressed, a hypersensitivity to carrageenans, unable to provide informed written consent,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported symptom scores; <br>Sino-nasal outcomes test - 22 questions/symptoms, each graded 0-5<br>[1) time of recruitment, <br>2) 2 weeks post-op/start of intervention, <br>3) 6-8 weeks post-op/start of intervention and <br>4) 3 months post-op/start of intervention/exit visit];Patient-reported symptom scores; <br>Visual analogues scale - 7 questions/symptoms, each graded 0-10cm<br><br>[1) time of recruitment, <br>2) 2 weeks post-op/start of intervention, <br>3) 6-8 weeks post-op/start of intervention and <br>4) 3 months post-op/start of intervention/exit visit];Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;<br>IL-6, [1) time of recruitment, <br>2) 2 weeks post-op/start of intervention, <br>3) 6-8 weeks post-op/start of intervention and <br>4) 3 months post-op/start of intervention/exit visit]