Effectiveness and Safety of Povidone-Iodine Irrigation for Postoperative Management of Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Lund-Kennedy Endoscopic Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal Saline Irrigation
Patients perform nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.
干预措施: Normal Saline Nasal Irrigation (Other)
Mucomyst Irrigation
Patients perform nasal irrigation using a mucomyst solution for 3 months after endoscopic sinus surgery.
干预措施: Acetylcysteine (Mucomyst) Nasal Irrigation (Drug)
Povidone-Iodine Irrigation
Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution after endoscopic sinus surgery.
干预措施: Povidone-Iodine Nasal Irrigation (Drug)
结局指标
主要结局
Lund-Kennedy Endoscopic Score
时间窗: 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)
时间窗: 3 months after endoscopic sinus surgery
Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions.
次要结局
- Sino-Nasal Outcome Test (SNOT-20) score(3 months after endoscopic sinus surgery)
- Distortion Product Otoacoustic Emission (DPOAE)(3 months after endoscopic sinus surgery)
研究者
Sung-Won Choi
Associate Professor, Department of Otorhinolaryngology-Head and Neck Surgery
Pusan National University Hospital