Betadine Effect on Nasal Mucosa Cilia

NCT ID: NCT04457765

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-09-30

Brief Summary

The goal of the proposed study is to identify PVP-I at 1.25% as an appropriate intranasal topical preparation for patients undergoing rhinoplasty with no effect on the nasal mucosa cilia (NMC) or olfaction using the saccharin transit time (STT) test as a method for evaluating NMC function. PVP-I has been shown to be viricidal in the upper aerodigestive tract. This study is highly-relevant, as protection for individuals with a high risk of exposure to respiratory pathogens has become increasingly important in the setting of recent viral epidemics such as SARS-CoV-2. Septorhinoplasty is commonly performed throughout the world and there is a paucity of standardized testing in surgical facilities. Much of our understanding of the current COVID-19 pandemic is extrapolated from MERS and SARS data. It is our hope that this study's relevance for the current pandemic remains so in the unfortunate event of another pandemic in the future.

Conditions

Rhinoplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

group 1

All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty

Group Type: EXPERIMENTAL

Povidone-Iodine (PVP-I)

Intervention Type: DRUG

1.25% Povidone-Iodine (PVP-I) (also known as betadine) to be used pre-procedure in the operating room via irrigation into the nasal cavity to act as viricidal preparation for the procedure. 240mL of 1.25% PVP-I will be distributed evenly among the right and left nasal cavities using a a 70mL syringe.

Interventions

Povidone-Iodine (PVP-I)

1.25% Povidone-Iodine (PVP-I) (also known as betadine) to be used pre-procedure in the operating room via irrigation into the nasal cavity to act as viricidal preparation for the procedure. 240mL of 1.25% PVP-I will be distributed evenly among the right and left nasal cavities using a a 70mL syringe.

Intervention Type: DRUG

Other Intervention Names

Betadine

Eligibility Criteria

Inclusion Criteria

• Patients at Boston Medical Center undergoing septorhinoplasty, without inferior turbinate reduction
• Normal range baseline saccharin transit time (STT)
• SARS-CoV-2 Testing Negative at the time of the procedure o Per institution guidelines, patients scheduled for surgery undergo a preoperative nasopharyngeal test within 24 hours of their procedure - per institution protocols.

Exclusion Criteria

• Known history of:

• thyroid dysfunction
• renal disease
• autoimmune disease affecting the upper airway
• immunocompromised
• pregnant, breastfeeding
• Patients determined to have dysfunctional nasal mucosa cilia (NMC) function based on a STT time of ≥30 minutes
• Patients with a contraindication to Povidone-iodine (PVP-I) including history of allergy/anaphylaxis to PVP-I, labile thyroid disease, history of contact dermatitis, active radioiodine therapy, pregnancy/nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Waleed Ezzat, MD

Role: STUDY_CHAIR

Boston Medical Center

Jennifer Shehan, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-40432

Identifier Type: -

Identifier Source: org_study_id