Effectiveness and Safety of Povidone-Iodine Irrigation for Postoperative Management of Chronic Rhinosinusitis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Lund-Kennedy Endoscopic Score
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Normal Saline Irrigation
Patients perform nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.
Intervention: Normal Saline Nasal Irrigation (Other)
Mucomyst Irrigation
Patients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery.
Intervention: Acetylcysteine (Mucomyst) Nasal Irrigation (Drug)
Povidone-Iodine Irrigation
Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution after endoscopic sinus surgery.
Intervention: Povidone-Iodine Nasal Irrigation (Drug)
Outcomes
Primary Outcomes
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.
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
- Sino-Nasal Outcome Test (SNOT-20) score(3 months after endoscopic sinus surgery)
- Distortion Product Otoacoustic Emission (DPOAE)(3 months after endoscopic sinus surgery)
Investigators
Sung-Won Choi
Associate Professor, Department of Otorhinolaryngology-Head and Neck Surgery
Pusan National University Hospital