Povidone-Iodine Nasal Irrigation After Surgery for Chronic Rhinosinusitis

Pusan National University

Status: Completed

Conditions: Chronic Rhinosinusitis

Treatments: Other: Normal Saline Nasal Irrigation; Drug: Acetylcysteine (Mucomyst) Nasal Irrigation; Drug: Povidone-Iodine Nasal Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07470242

PNUH-IRB-2110-009-107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Normal Saline Irrigation

Active Comparator group

Description:

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

Treatment:

Other: Normal Saline Nasal Irrigation

Mucomyst Irrigation

Active Comparator group

Description:

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

Treatment:

Drug: Acetylcysteine (Mucomyst) Nasal Irrigation

Povidone-Iodine Irrigation

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine Nasal Irrigation