NCT01895933已完成不适用
The Aim of This Study is to Evaluate the Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel Made by D Med
D.med3 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Adhesion Rate
研究概览
简要总结
This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 21 years of age
- •both side sinusitis
- •will undergo endoscopic sinus surgery
- •volunteers with informed consent and signature
排除标准
- •suppressed immunity patient
- •systemic grave condition
- •severe disease patients
- •asthma patients
- •cystic fibrosis
- •ciliary immobility syndrome
- •neutropenia neutrophil
- •immunoglobulin deficiency
- •wound healing immune disease
- •severe liver disease
- •severe kidney disease
- •lymph or blood clotting disorder or patients treated with coagulants
- •patients taking oral or parenteral glucose for diabetes thrombocytopenia
- •infectious disease
- •currently lactating
- •severe septal deviation
- •case where there is a severe difference in sinusitis state between sides of nose: there is a 3 or more score difference on the Lund-Mackey CT scan scoring system PNS(ParaNasalSinus)
- •shellfish allergy
- •food allergy
- •had endoscopic sinus surgery in the past
- •patient with large sinus polyps
- •patients who have received treatment for extrasinus complication
结局指标
主要结局
Adhesion Rate
时间窗: at 2 weeks
Adhesion rate at 2 weeks after ESS(endoscopic sinus surgery)
次要结局
- Adhesion Rate(at 1 and 4 weeks)
研究者
研究点 (3)
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