ChiCTR2100043282Active, not recruitingPhase 4
局部应用巴曲酶注射液预防鼓室成形术后鼓室黏连的前瞻性、随机、病例对照研究
研究者1 site in 1 country122 target enrollmentStarted: February 10, 2021Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- 鼓室粘连
Study Overview
Brief Summary
观察局部应用巴曲酶注射液对鼓室成形术后鼓室粘连的预防作用，观察局部应用巴曲酶注射液术后患者鼓膜愈合和听力改善情况； 评价局部应用巴曲酶注射液的安全性；分析鼓室成形术后影响听力改善的因素。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 未说明
Eligibility Criteria
- Ages
- 18 to 60 (—)
- Sex
- All
Inclusion Criteria
- •年龄 18-60 岁；
- •符合慢性化脓性中耳炎或中耳胆脂瘤诊断，术中明确有鼓室内侧壁黏膜缺损或病变；
- •镫骨或镫骨底板（或处理后）动度好，行 II 或Ⅲ型鼓室成形术；
- •纯音测听结果为传导性耳聋或混合性耳聋（平均骨导≤30dB），且气骨导差≥30dB。
Exclusion Criteria
- •1）既往有患耳手术或外伤史；
- •行上鼓室切开重建、开放式鼓室成形等其它类型鼓室成形术患者；
- •3）合并腭裂等影响中耳功能的先天性疾病；
- •4）术前患者纤维蛋白原<1.0g/L
- •5）无法按要求复查者。
Arms & Interventions
试验组
鼓室填塞混合巴曲酶注射液的明胶海绵
对照组
鼓室填塞地塞米松混合的明胶海绵
Outcomes
Primary Outcomes
鼓室粘连
鼓膜愈合
听力改善
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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