Status:
WITHDRAWN
Betadine Effect on Nasal Mucosa Cilia
Lead Sponsor:
Boston Medical Center
Conditions:
Rhinoplasty
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 olfa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04457765
Start Date
April 1 2021
End Date
September 1 2022
Last Update
February 12 2021
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118