AzTrials
AzTrials

RhinoplastyEarly Phase 1NCT04457765

Betadine Effect on Nasal Mucosa Cilia

A Early Phase 1 study testing Povidone-Iodine (PVP-I) in people with Rhinoplasty, run by Boston Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rhinoplasty
What is being tested?
Povidone-Iodine (PVP-I)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2021to Sep 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: 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.

Conditions
Rhinoplasty
Being tested
Povidone-Iodine (PVP-I)
Keywords
Septorhioplasty, Povidine-Iodine (PVP-I), Betadine, Nasal mucosa cilia (NMC), Saccharin transit time (STT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Povidone-Iodine (PVP-I)Drug

    Also called Betadine

    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.

Study groups in NCT04457765
Study groupRoleWhat they receive
group 1ExperimentalAll participants will have PVP-I at 1.25% administered as an intranasal topical preparation prior undergoing rhinoplasty
Receives: Drug: Povidone-Iodine (PVP-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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.

    Measured: 5 weeks

Secondary outcomes (5)

  1. 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.

    Measured: baseline, 5 weeks

  2. 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.

    Measured: baseline, 5 weeks

  3. 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.

    Measured: baseline, 5 weeks

  4. Preoperative clinical examination of nasal mucosa

    A through preoperative clinical examination of each participant will be done and findings documented.

    Measured: baseline

  5. Post operative clinical examination of nasal mucosa

    A through postoperative clinical examination of each participant will be done and findings documented.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study startApr 2021 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (estimated)

Why it stopped: The IRB did not approve the study to be conducted at the home institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457765
Sponsor's protocol ID
H-40432
Status last verified
Feb 2021
First submitted
30 Jun 2020
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Povidone-Iodine (PVP-I) in people with Rhinoplasty, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative nasal mucosa cilia (NMC) function (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in