Betadine Effect on Nasal Mucosa Cilia

Early Phase 1

Withdrawn

• Conditions: Rhinoplasty
• Interventions: Drug: Povidone-Iodine (PVP-I)

• Registration Number: NCT04457765
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-12
• Study Start: 2021-04
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group 1	Povidone-Iodine (PVP-I)	All participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty

Primary Outcome Measures

Name	Time	Method
Preoperative nasal mucosa cilia (NMC) function	baseline	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.
Postoperative nasal mucosa cilia (NMC) function	5 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in self reported symptoms of nasal blockage or obstruction	baseline, 5 weeks	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.
Change in olfactory function	baseline, 5 weeks	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.
Change in quality of life based on sino-nasal symptoms	baseline, 5 weeks	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.
Preoperative clinical examination of nasal mucosa	baseline	A through preoperative clinical examination of each participant will be done and findings documented.
Post operative clinical examination of nasal mucosa	5 weeks	A through postoperative clinical examination of each participant will be done and findings documented.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States