Effectiveness of Maxillary Sinus Saline Irrigation in Conjunction With Systemic Antibiotic Therapy Versus Systemic Antibiotic Therapy Alone in the Management of Chronic Rhinosinusitis, a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CT Scoring
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.
详细描述
Effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis. A prospective randomized controlled trial is being conducted in Carmel Medical Center, Haifa, Israel. Patients are being randomized into one of two arms. One arm receives sinus irrigation with saline in conjunction with IV antibiotics, the control arm receives the same regimen of IV antibiotics without the sinus irrigation. Quality of life, CT scans and nasal endoscopy parameters are collected before and after treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT scan)
- •Over 18 years of age
- •Signed informed consent
- •Not participating in another clinical study
- •Exclusion criteria:
- •A previous sinonasal surgery or craniofacial trauma
- •Isolated frontal or sphenoidal sinusitis
- •Immunosuppressed (diabetes, cancer, etc.)
- •Craniofacial deformity
- •Allergic fungal sinusitis
- •Nasal polyposis
- •Rhinosinusitis of dental origin
- •Bleeding tendency (e.g., chronic coumadin treatment)
- •Patients participating in other clinical study
- •Patients with penicillin allergy
- •Patients with Augmentin resistant bacteria in cultures
排除标准
- 未提供
研究组 & 干预措施
1
The Investigational arm is treated with sinus irrigation with normal saline 0.9% and intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.
干预措施: Maxillary Sinus Irrigation (Procedure)
2
The control arm is treated with the same intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. There is no sinus irrigation with normal saline for this arm. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.
干预措施: IV Amoxicillin and Clavulanate acid (Drug)
结局指标
主要结局
CT Scoring
时间窗: on recruiting and follow-up
次要结局
- Quality of life Questionaire(on recruiting and follow-up)
- Nasal Endoscopy score(upon recruiting and follow-up)
研究者
Ohad Ronen
ENT Physician
Carmel Medical Center