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Povidone-Iodine Rinses as an Adjuvant Therapy Post-Operatively

NCT04278950 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-02-20

No results posted yet for this study

Summary

Povidone Iodine solution is a nasal antiseptic. Its application has been shown to be clinically safe, tolerable and effective against bacteria and fungi associated with chronic rhinosinusitis.

The purpose of this study is determining the effectiveness of PVP-I in comparison to a placebo for post-operative refractory CRS patients in a randomized controlled trial.

Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Interventions

DRUG

Povidone-Iodine

For the PVP-I group, the final concentration of available iodine in the solution will be 0.01%, (from diluting 10% PVP-I solution), as previously demonstrated to be below ciliotoxic levels of 1.25% and greater than 0.01% which is the lower limit of active potency.

DRUG

Placebos

The placebo will be 2.5mL of saline with brown food coloring.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin Javer, MD · University of British Columbia and St. Paul's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-02-10
Completion
2021-02-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278950 on ClinicalTrials.gov