Povidone-Iodine Nasal Irrigation After Surgery for Chronic Rhinosinusitis

March 9, 2026 updated by: Sung-Won Choi, Pusan National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Pusan, South Korea, 49241
        • Pusan National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Postoperative nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.
Active Comparator: Mucomyst Irrigation
Patients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery.
Drug: Acetylcysteine (Mucomyst) Nasal Irrigation
Postoperative nasal irrigation using acetylcysteine solution for 3 months after endoscopic sinus surgery.
Experimental: Povidone-Iodine Irrigation
Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution after endoscopic sinus surgery.
Drug: Povidone-Iodine Nasal Irrigation
Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution for 3 months after endoscopic sinus surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund-Kennedy Endoscopic Score
Time Frame: 3 months after endoscopic sinus surgery
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)
Time Frame: 3 months after endoscopic sinus surgery
Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions.
3 months after endoscopic sinus surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino-Nasal Outcome Test (SNOT-20) score
Time Frame: 3 months after endoscopic sinus surgery
Patient-reported sinonasal symptoms and disease-specific quality of life assessed using the Sino-Nasal Outcome Test-20 questionnaire.
3 months after endoscopic sinus surgery
Distortion Product Otoacoustic Emission (DPOAE)
Time Frame: 3 months after endoscopic sinus surgery
Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions.
3 months after endoscopic sinus surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

August 7, 2023

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNUH-IRB-2110-009-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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