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CompletedNCT07470242Updated Mar 13, 2026

Povidone-Iodine Nasal Irrigation After Surgery for Chronic Rhinosinusitis

An interventional study of Normal Saline Nasal Irrigation and Acetylcysteine (Mucomyst) Nasal Irrigation in Chronic Rhinosinusitis, sponsored by Pusan National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Pusan National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Oct 2021, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Rhinosinusitis

Keywords

  • Nasal Irrigation
  • Povidone-Iodine
  • Endoscopic Sinus Surgery
  • Mucomyst
  • Chronic Rhinosinusitis
  • povidone-iodine ototoxicity
03

In context

Lead sponsor

Pusan National University Hospital is the lead sponsor of 78 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Normal Saline Irrigation

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

    Other: Normal Saline Nasal Irrigation

  • Active comparator
    Mucomyst Irrigation

    Patients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery.

    Drug: Acetylcysteine (Mucomyst) Nasal Irrigation

  • Experimental
    Povidone-Iodine Irrigation

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

    Drug: Povidone-Iodine Nasal Irrigation

Interventions

  • OtherNormal Saline Nasal Irrigation

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

  • DrugAcetylcysteine (Mucomyst) Nasal Irrigation

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

  • DrugPovidone-Iodine Nasal Irrigation

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

06

What researchers measure

Primary outcomes

  1. Lund-Kennedy Endoscopic Score

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

    Time frame: 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.

    Time frame: 3 months after endoscopic sinus surgery

Secondary outcomes

  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.

    Time frame: 3 months after endoscopic sinus surgery

  2. Distortion Product Otoacoustic Emission (DPOAE)

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

    Time frame: 3 months after endoscopic sinus surgery

07

Study locations

1 site
  • Pusan National University Hospital
    Pusan, 49241, South Korea
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07470242
Lead sponsor
Pusan National University Hospital
Responsible party
Sung-Won Choi (Associate Professor, Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University Hospital) — Principal investigator
First posted
Mar 13, 2026
Start date
Oct 13, 2021
Primary completion
Mar 7, 2023
Completion
Aug 7, 2023
Last update
Mar 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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