NCT00746707已完成不适用
Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Functional and cosmetic evaluation of perineal tear area.
研究概览
简要总结
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
详细描述
This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears
排除标准
- •excessive bleeding,
- •chronic steroid treatment,
- •immunosuppressive treatment,
- •active infection,
- •allergy to Dermabond or Histoacryl
结局指标
主要结局
Functional and cosmetic evaluation of perineal tear area.
时间窗: At least six weeks after birth
次要结局
- Assessment of pain at least six weeks after delivery(At least six weeks after delivery)
研究者
Ezra Yosi
MD
Hadassah Medical Organization
研究点 (2)
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