Sterimar vs Saline Sprays in Nasal Surgical Aftercare - a Blinded, Randomised Trial
试验速览
- 阶段
- 4 期
- 发起方
- NHS Grampian
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS.
研究概览
简要总结
Patients undergoing nasal surgery commonly experience a variety of symptoms in the post-operative period including blockage, running, pain, bleeding and reduction in sense of smell. A variety of preparations are currently recommended for symptomatic relief in the post operative period. These include saline irrigations and sniffs, steam inhalations, decongestants and steroid drops.
There is currently no level 1 evidence in literature to support the use of any particular preparation over others in nasal surgical aftercare.
We propose to conduct a single blinded, randomised trial comparing saline sprays vs Sterimar, a commercially available aerosolised isotone saline solution, comparing patients' symptom scores following septal surgery.
The trial will help to establish efficacy and symptom control and advantages of one solution and delivery device over the other.
详细描述
Project Proposal
Sterimar vs Saline Sprays in nasal surgical aftercare - a blinded, randomised trial.
Gundula Thiel, Andy Evans, Kim Ah-See
Background
Patients undergoing nasal surgery commonly experience a variety of symptoms in the post-operative period including blockage, running, pain, bleeding and reduction in sense of smell. A variety of preparations are currently recommended for symptomatic relief in the post operative period. These include saline irrigations and sniffs, steam inhalations, decongestants and steroid drops. These are intended to reduce swelling and crusting and their resultant symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing septoplasty and septoplasty in conjuction with turbinate surgery will be recruited.
排除标准
- •Those undergoing additional procedures including polypectomy will be excluded, as will all patients whose post-operative recommendations are for steroids or other take home medications that may bias results.
研究组 & 干预措施
1
Nasal Sterimar spray
干预措施: Sterimar Spray (Drug)
2
Nasal saline spray
干预措施: Generic homemade nasal saline spray (salt and water) (Drug)
结局指标
主要结局
On the 3rd and 7th postoperative day, patients will judge their symptoms on that day, using VAS.
时间窗: Day 3 and 7
次要结局
- The patient should record painkillers needed on a daily basis for 7 days and will be provided with an EQ-5D health questionnaire.(7 days)