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Chronic RhinosinusitisNCT07470242

Povidone-Iodine Nasal Irrigation After Surgery for Chronic Rhinosinusitis

A study testing Normal Saline Nasal Irrigation, Acetylcysteine (Mucomyst) Nasal Irrigation and Povidone-Iodine Nasal Irrigation in people with Chronic Rhinosinusitis, run by Pusan National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective randomized controlled trial evaluates the effectiveness and safety of different nasal irrigation solutions for postoperative care after endoscopic sinus surgery in patients with chronic rhinosinusitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Rhinosinusitis
What is being tested?
Normal Saline Nasal Irrigation, Acetylcysteine (Mucomyst) Nasal Irrigation and Povidone-Iodine Nasal Irrigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
13 Oct 2021to 7 Aug 2023
Phase
Interventional
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

  • Adult patients diagnosed with chronic rhinosinusitis
  • Patients who underwent endoscopic sinus surgery (ESS)
  • Patients who performed postoperative nasal irrigation for 3 months
  • Patients who completed the follow-up evaluation and agreed to participate in the study

Who cannot join

  • History of chronic otitis media
  • Presence of otitis media with effusion at the time of evaluation
  • History of previous middle ear surgery
  • Known allergy to povidone-iodine
  • Incomplete follow-up data
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Pusan National University Hospital

    Pusan, 49241

Other trials in South Korea

About this study

Official title: Effectiveness and Safety of Povidone-Iodine Irrigation for Postoperative Management of Chronic Rhinosinusitis

This prospective randomized controlled trial evaluates the effectiveness and safety of different nasal irrigation solutions for postoperative care after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients undergoing endoscopic sinus surgery will be randomly assigned to receive nasal irrigation with normal saline, mucomyst, or diluted povidone-iodine solution for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and potential ototoxic effects will be evaluated to compare the effectiveness and safety of these irrigation methods.

Read the detailed description

Chronic rhinosinusitis is a common inflammatory disease characterized by symptoms such as nasal obstruction, nasal discharge, facial pressure, and decreased sense of smell. Endoscopic sinus surgery (ESS) is often performed in patients whose symptoms do not improve with medical treatment. Postoperative nasal irrigation is widely used to promote mucosal healing and remove secretions in the nasal cavity and paranasal sinuses.

Povidone-iodine has broad-spectrum antimicrobial activity and is commonly used as a disinfectant. It has been suggested that diluted povidone-iodine solution may improve postoperative wound healing and provide additional antimicrobial effects when used as a nasal irrigation solution. However, concerns exist regarding the potential ototoxicity of povidone-iodine if it enters the middle ear during irrigation.

This prospective randomized controlled trial aims to evaluate the effectiveness and safety of nasal irrigation using normal saline, mucomyst, or diluted povidone-iodine solution after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients will receive nasal irrigation for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and hearing-related tests including pure tone audiometry, tympanometry, and distortion product otoacoustic emissions will be evaluated to assess treatment effectiveness and potential ototoxicity.

Being tested
Normal Saline Nasal Irrigation, Acetylcysteine (Mucomyst) Nasal Irrigation, Povidone-Iodine Nasal Irrigation
Keywords
Nasal Irrigation, Povidone-Iodine, Endoscopic Sinus Surgery, Mucomyst, Chronic Rhinosinusitis, povidone-iodine ototoxicity

What participants receive

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

  • Normal Saline Nasal IrrigationOther

    Postoperative nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.

  • Acetylcysteine (Mucomyst) Nasal IrrigationDrug

    Postoperative nasal irrigation using acetylcysteine solution for 3 months after endoscopic sinus surgery.

  • Povidone-Iodine Nasal IrrigationDrug

    Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution for 3 months after endoscopic sinus surgery.

Study groups in NCT07470242
Study groupRoleWhat they receive
Normal Saline IrrigationActive comparatorPatients perform nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.
Receives: Other: Normal Saline Nasal Irrigation
Mucomyst IrrigationActive comparatorPatients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery.
Receives: Drug: Acetylcysteine (Mucomyst) Nasal Irrigation
Povidone-Iodine IrrigationExperimentalPostoperative nasal irrigation using diluted 0.5% povidone-iodine solution after endoscopic sinus surgery.
Receives: Drug: Povidone-Iodine Nasal Irrigation

What is being measured

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

  1. Lund-Kennedy Endoscopic Score

    Postoperative sinonasal status evaluated by nasal endoscopy using the Lund-Kennedy endoscopic scoring system.

    Measured: 3 months after endoscopic sinus surgery

  2. Hearing function assessed by pure tone audiometry (PTA)

    Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions.

    Measured: 3 months after endoscopic sinus surgery

Secondary outcomes (2)
  1. Sino-Nasal Outcome Test (SNOT-20) score

    Patient-reported sinonasal symptoms and disease-specific quality of life assessed using the Sino-Nasal Outcome Test-20 questionnaire.

    Measured: 3 months after endoscopic sinus surgery

  2. Distortion Product Otoacoustic Emission (DPOAE)

    Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions.

    Measured: 3 months after endoscopic sinus surgery

Timeline

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

  1. First posted13 Mar 2026
  2. Study start13 Oct 2021
  3. Primary completion7 Mar 2023
  4. Study completion7 Aug 2023

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
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470242
Sponsor's protocol ID
PNUH-IRB-2110-009-107
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Panchmatia R, Payandeh J, Al-Salman R, Kakande E, Habib AR, Mullings W, Javer AR. The efficacy of diluted topical povidone-iodine rinses in the management of recalcitrant chronic rhinosinusitis: a prospective cohort study. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3373-3381. doi: 10.1007/s00405-019-05628-w. Epub 2019 Sep 27.

    PubMed 31560120
  • Ramezanpour M, Smith JLP, Psaltis AJ, Wormald PJ, Vreugde S. In vitro safety evaluation of a povidone-iodine solution applied to human nasal epithelial cells. Int Forum Allergy Rhinol. 2020 Oct;10(10):1141-1148. doi: 10.1002/alr.22575. Epub 2020 Jun 7.

    PubMed 32250552
  • Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.

    PubMed 32301284
  • Mady LJ, Kubik MW, Baddour K, Snyderman CH, Rowan NR. Consideration of povidone-iodine as a public health intervention for COVID-19: Utilization as "Personal Protective Equipment" for frontline providers exposed in high-risk head and neck and skull base oncology care. Oral Oncol. 2020 Jun;105:104724. doi: 10.1016/j.oraloncology.2020.104724. Epub 2020 Apr 16. No abstract available.

    PubMed 32317139
  • Kim JH, Rimmer J, Mrad N, Ahmadzada S, Harvey RJ. Betadine has a ciliotoxic effect on ciliated human respiratory cells. J Laryngol Otol. 2015 Jan;129 Suppl 1:S45-50. doi: 10.1017/S0022215114002746. Epub 2014 Nov 3.

    PubMed 25363372
  • Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.

    PubMed 29633177
  • Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.

    PubMed 26416214
  • Lepelletier D, Maillard JY, Pozzetto B, Simon A. Povidone Iodine: Properties, Mechanisms of Action, and Role in Infection Control and Staphylococcus aureus Decolonization. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00682-20. doi: 10.1128/AAC.00682-20. Print 2020 Aug 20.

    PubMed 32571829
  • Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.

    PubMed 22311838
  • Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab M, Lanza D. Long-term results of functional endoscopic sinus surgery. Laryngoscope. 1998 Feb;108(2):151-7. doi: 10.1097/00005537-199802000-00001.

    PubMed 9473061
  • Lee VS, Pottinger PS, Davis GE. Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis. Am J Otolaryngol. 2020 Sep-Oct;41(5):102604. doi: 10.1016/j.amjoto.2020.102604. Epub 2020 Jun 6.

    PubMed 32563787
  • Zhao K, Craig JR, Cohen NA, Adappa ND, Khalili S, Palmer JN. Sinus irrigations before and after surgery-Visualization through computational fluid dynamics simulations. Laryngoscope. 2016 Mar;126(3):E90-6. doi: 10.1002/lary.25666. Epub 2015 Oct 15.

    PubMed 26467934
  • Wu PH, Cheng PC, Chang CM, Lo WC, Cheng PW. Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study. Laryngoscope. 2022 Jun;132(6):1148-1152. doi: 10.1002/lary.29818. Epub 2021 Aug 16.

    PubMed 34397104
  • Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.

    PubMed 25832968
  • Steele TO, Gill A, Tollefson TT. Contemporary considerations in concurrent endoscopic sinus surgery and rhinoplasty. Curr Opin Otolaryngol Head Neck Surg. 2018 Aug;26(4):209-213. doi: 10.1097/MOO.0000000000000469.

    PubMed 29894317

Questions about this trial

What is this clinical trial studying?

A study testing Normal Saline Nasal Irrigation, Acetylcysteine (Mucomyst) Nasal Irrigation and Povidone-Iodine Nasal Irrigation in people with Chronic Rhinosinusitis, run by Pusan National University Hospital at 1 site in South Korea.

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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Mar 2026. 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 South Korea. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Lund-Kennedy Endoscopic Score (time frame: 3 months after endoscopic sinus surgery). 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 NCT07470242, which also lists 15 linked publications.

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 13 Mar 2026.

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