NCT00140608终止不适用
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery
Genzyme, a Sanofi Company3 个研究点 分布在 1 个国家开始时间: 2003年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 试验地点
- 3
- 主要终点
- reduction in post-operative scarring when compared to use of no sinus packing
研究概览
简要总结
The purpose of this study is to investigate if the space occupying effect of Seprapack will lead to a reduction in post operative adhesions and more healing of the sinus cavity when compared to the use of no packing material.
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
- Single
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
- •at least 18 years of age
- •requiring bilateral endoscopic ethmoidectomy (anterior or posterior)
- •intact middle turbinates
- •willing to return for all follow-up visits
- •signed written informed consent
排除标准
- •patients with craniofacial abnormalities (e.g. cleft palate)
- •patients without intact middle turbinates
- •patients on long-term oral steroids or other chemotherapeutic agents that might delay healing. Short-term pulse steroid therapy and topical steroids are acceptable
- •patients with inflammatory conditions, other than chronic sinusitis or nasal polyposis, including but not limited to sarcoidosis, rhinitis, ozena, Wegner's granulomatosis, nasal malignancy, recreational drug abuse
- •patients with cystic fibrosis
- •women that are pregnant or women of childbearing age potential who are not practicing an acceptable method of birth control
- •patients with bleeding disorders or who are receiving anticoagulants
- •patients that may require a Lothrop procedure
结局指标
主要结局
reduction in post-operative scarring when compared to use of no sinus packing
次要结局
未报告次要终点
研究者
研究点 (3)
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