NCT07470242

Povidone-Iodine Nasal Irrigation After Surgery for Chronic Rhinosinusitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
OTHER	Normal Saline Nasal Irrigation	Postoperative nasal irrigation using normal saline 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.
DRUG	Povidone-Iodine Nasal Irrigation	Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution for 3 months after endoscopic sinus surgery.

Timeline

• Start date: 2021-10-13
• Primary completion: 2023-03-07
• Completion: 2023-08-07
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: South Korea