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Completed

NCT Number: NCT07470242

Povidone-Iodine Nasal Irrigation After Surgery for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital

Pusan, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline Nasal Irrigation

Other

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

Acetylcysteine (Mucomyst) Nasal Irrigation

Drug

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

Povidone-Iodine Nasal Irrigation

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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