Povidone-Iodine Rinses as an Adjuvant Therapy Post-Operatively

NCT04278950 | Unknown

• 1 other identifier: H19-02292
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Betadine; Poviodine Iodine; CRS; Biofilm; Postoperative

Outcome Measures

Primary Outcomes (2)

• Modified Lund-Kennedy endoscopic scores

  This score is based on the endoscopic assessment of polyps, edema, and discharge and are each given score 0-2. A higher score indicates a worse outcome.

  6 months

• Cultures and Sensitivity

  Assess whether there is positive growth of bacteria or fungi.

  6 months

Secondary Outcomes (5)

• SNOT-22

  6 months

• Blood test

  6 months

• Saccharin test

  6 months

• Sniffin' Stick smell test

  6 months

• Blood test

  6 months

Study Arms (2)

Poviodine Iodine Solution

ACTIVE COMPARATOR

Patients will be randomized into this arm will be provided with 0.10% PVP-I (0.01% available iodine). Patients will be instructed to dilute 2.5mL of the betadine (unmarked bottles) into a 240mL bottle of saline and rinse once per day.

Drug: Povidone-Iodine

Placebo Poviodine Iodine Solution

PLACEBO COMPARATOR

Patients will be randomized into this arm will be provided with a placebo PVP-I solution. Patients will be instructed to dilute 2.5mL of the placebo PVP-I (unmarked bottles) into a 240mL bottle of saline and rinse once per day.

Drug: Placebos

Interventions

Povidone-Iodine DRUG

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.

Also known as: Betadine

Poviodine Iodine Solution

Placebos DRUG

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

Placebo Poviodine Iodine Solution

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Undergoing FESS at St. Paul's Hospital or False Creek Surgical Centre

You may not qualify if:

• Patients with sinonasal tumors.
• Patients who previously used PVP-I rinses - Patients with autoimmune diseases affecting the upper airway
• eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc.
• Immuno-compromised patients, and patients with impairment in mucociliary function
• (e.g., cystic fibrosis, Kartagener syndrome)
• Hypersensitivity to iodine
• History of thyroid disorders including thyroid cancer, hyperthyroidism and hypothyroidism
• Use of medications for thyroid disorders including thyroxine and carbimazole
• Pregnancy
• Patients unable to speak English.

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

MeSH Terms

Conditions

Disease

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Amin Javer, MD

  University of British Columbia and St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atenea Pascual

CONTACT

(604) 806-9926; apascual@providencehealth.bc.ca

Laura Samson

CONTACT

(604) 806-9926; lsamson2@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 20, 2020
• Study Start: February 10, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02