Betadine Effect on Nasal Mucosa Cilia

Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Rhinoplasty
• Intervention / Treatment: Drug: Povidone-Iodine (PVP-I)

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty	Drug: 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.; Other Names: Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative nasal mucosa cilia (NMC) function	NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT >30.	baseline
Postoperative nasal mucosa cilia (NMC) function	NMC will be assessed with the saccharin transit time (STT) test. This test is done by the examiner inserting sodium saccharin particle on the upper surface of the inferior nasal turbinate.The patient is instructed to swallow once every minute and notify the examiner when they notice a sweet taste. The distance from the start of the mucociliary membrane to far wall of pharynx is measured with a probe. From this measurement, the mean velocity is calculated compared to the total time from the start of the test. Dysfunction is defined as a STT >30.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self reported symptoms of nasal blockage or obstruction	Nasal symptoms will be assessed with the NOSE (Nasal Obstruction Symptom Evaluation) Tool. NOSE has 5 questions and response options for each range from 0 to 4 where 0= Not a problem, 1= Mild problem, 2= Moderate problem, 3= Significant problem, 4= Severe problem. The response value for each question is multiplied by 5 so overall NOSE scores can range from 0 to 100 and are interpreted as-- 0: Nothing to worry about; 5 - 25: Mild obstruction; 26 - 50: Moderate obstruction; 51 - 75: Significant obstruction; 76 - 100: Severe obstruction.	baseline, 5 weeks
Change in olfactory function	The participant will be instructed to sniff repetitively and to tell when an odor is detected, identifying the odor if recognized. The test odor up to within 30 cm or less of the nose.	baseline, 5 weeks
Change in quality of life based on sino-nasal symptoms	Participants' quality of life will be assessed using the Sino-nasal Outcome Test (SNOT-22). This is a self administered questionnaire with 22 items. Each items is answered by selecting one of 6 categories where 0 = No problem, 1 = Very Mild problem, 2 = Mild or slight problem, 3 = Moderate problem, 4 = Severe problem, 5 = Problem as bad as it can be. Scores can range from 0 to 110. A score of 7 or below is considered 'normal' scores 8 or above suggests that sino-nasal symptoms are affecting participants' quality of life.	baseline, 5 weeks
Preoperative clinical examination of nasal mucosa	A through preoperative clinical examination of each participant will be done and findings documented.	baseline
Post operative clinical examination of nasal mucosa	A through postoperative clinical examination of each participant will be done and findings documented.	5 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Study Chair: Waleed Ezzat, MD, Boston Medical Center; Principal Investigator: Jennifer Shehan, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Betadine; Septorhioplasty; Povidine-Iodine (PVP-I); Nasal mucosa cilia (NMC); Saccharin transit time (STT)
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: H-40432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes