NCT07470242

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Chronic Rhinosinusitis

Keywords

Nasal IrrigationPovidone-IodineEndoscopic Sinus SurgeryMucomystChronic Rhinosinusitispovidone-iodine ototoxicity

Outcome Measures

Primary Outcomes (2)

  • Lund-Kennedy Endoscopic Score

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

    3 months after endoscopic sinus surgery

  • Hearing function assessed by pure tone audiometry (PTA)

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

    3 months after endoscopic sinus surgery

Secondary Outcomes (2)

  • Sino-Nasal Outcome Test (SNOT-20) score

    3 months after endoscopic sinus surgery

  • Distortion Product Otoacoustic Emission (DPOAE)

    3 months after endoscopic sinus surgery

Study Arms (3)

Normal Saline Irrigation

ACTIVE COMPARATOR

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

Other: Normal Saline Nasal Irrigation

Mucomyst Irrigation

ACTIVE COMPARATOR

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

Drug: Acetylcysteine (Mucomyst) Nasal Irrigation

Povidone-Iodine Irrigation

EXPERIMENTAL

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

Drug: Povidone-Iodine Nasal Irrigation

Interventions

Normal Saline Nasal IrrigationOTHER

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

Normal Saline Irrigation
Acetylcysteine (Mucomyst) Nasal IrrigationDRUG

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

Mucomyst Irrigation
Povidone-Iodine Nasal IrrigationDRUG

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

Povidone-Iodine Irrigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Pusan, 49241, South Korea

Location

Related Publications (15)

  • 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.

    PMID: 31560120BACKGROUND

  • 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.

    PMID: 32250552BACKGROUND

  • 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.

    PMID: 32301284BACKGROUND

  • 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.

    PMID: 32317139BACKGROUND

  • 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.

    PMID: 25363372BACKGROUND

  • 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.

    PMID: 29633177BACKGROUND

  • 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.

    PMID: 26416214BACKGROUND

  • 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.

    PMID: 32571829BACKGROUND

  • 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.

    PMID: 22311838BACKGROUND

  • 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.

    PMID: 9473061BACKGROUND

  • 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.

    PMID: 32563787BACKGROUND

  • 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.

    PMID: 26467934BACKGROUND

  • 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.

    PMID: 34397104BACKGROUND

  • 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.

    PMID: 25832968BACKGROUND

  • 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.

    PMID: 29894317BACKGROUND

MeSH Terms

Interventions

AcetylcysteineNasal Lavage

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsTherapeutic IrrigationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Otorhinolaryngology-Head and Neck Surgery

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

October 13, 2021

Primary Completion

March 7, 2023

Study Completion

August 7, 2023

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

KR(1)