Betadine Effect on Nasal Mucosa Cilia

Boston Medical Center (BMC)

Status and phase: Withdrawn; Early Phase 1

Conditions: Rhinoplasty

Treatments: Drug: Povidone-Iodine (PVP-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT04457765

H-40432

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

group 1

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine (PVP-I)