A double-blinded randomised control human clinical trial evaluating the safety and effectiveness of colloidal silver sinonasal rinse versus standard of care on post-operative symptomatic outcomes in the treatment of Chronic Rhinosinusitis in adults.

Phase 1

Recruiting

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

• Registration Number: ACTRN12623000011684
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Participants must have had at least two of the following symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure or lack of sense of smell) that has been previously persistent for greater than 3 months.
Participants must have had endoscopic sinus surgery (ESS) and be able to start the trial anytime from two weeks post-operative.
Participants must show evidence of chronic sinusitis by direct endoscopic examination. Participants must show evidence of infectious exacerbation by direct endoscopic examination and have a positive culture diagnosis with pathogens that show sensitivity to mupirocin and/or tobramycin and/or oral antibiotic.
Participants must have the ability to administer daily sinus rinses for the duration of the treatment period.
Participants must be aged 18 years or over.
Participants must be able to give written informed consent.
Participants must have the ability and willingness to attend several visits to the outpatients.
Participants must have the willingness and ability to comply with the requirements of the protocol as determined by the Investigator.

Exclusion Criteria

Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study. Pregnant and breastfeeding women will also be excluded.
Participants who are actively taking oral steroids or antibiotics will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified