JPRN-UMIN000026530已完成2 期
Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients. - Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
This study showed the safety of use of INTEGRAN for staple-line coverage in pneumothorax surgery in young adults. The short-term recurrence rate was acceptable given the high-risk cohort examined in the study. A prospective randomized controlled study is needed for evaluation of the efficacy of INTEGRAN for prevention of recurrence of PSP.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 25years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Secondary spontaneous pneumothorax patients (2)Synchronous bilateral pneumothorax patients (3)Patients with shock vital sign (Systolic blood pressure <80 mmHg and HR > 100 bpm) or with hemothorax more than 1,000 ml (4)With medical history of ipsilateral thoracic surgery. (5)Patients with hypersensitivity to bovine derived products (insulin, glucagon etc.) (6)Patients with pregnancy (7)Patients who are assessed by investigator as "inadequate for enrollment" .
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