Clinical trial NCT04457765: Betadine Effect on Nasal Mucosa Cilia
Official title: Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Rhinoplasty
Keywords: Septorhioplasty
Povidine-Iodine (PVP-I)
Betadine
Nasal mucosa cilia (NMC)
Saccharin transit time (STT)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Preoperative nasal mucosa cilia (NMC) function
timeFrame: baseline
measure: Postoperative nasal mucosa cilia (NMC) function
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in self reported symptoms of nasal blockage or obstruction
timeFrame: baseline, 5 weeks
measure: Change in olfactory function
timeFrame: baseline, 5 weeks
measure: Change in quality of life based on sino-nasal symptoms
timeFrame: baseline, 5 weeks
measure: Preoperative clinical examination of nasal mucosa
timeFrame: baseline
measure: Post operative clinical examination of nasal mucosa
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Waleed Ezzat, MD
role: STUDY_CHAIR
affiliation: Boston Medical Center
name: Jennifer Shehan, MD
role: PRINCIPAL_INVESTIGATOR
References: