NCT00840788已完成不适用
Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Self-assessed perineal pain
研究概览
简要总结
Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.
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 (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •vaginal delivery
- •episiotomy performed
- •no further perineal or vaginal lesions present
排除标准
- •previously existing local infections or lesions
- •body mass index > 35 (Kg/m2)
- •severe pulmonary disease
- •collagen disease
- •known immunodeficiency
- •diabetes mellitus
- •immunosuppressive treatment
结局指标
主要结局
Self-assessed perineal pain
时间窗: First 30 days after delivery
次要结局
- Pain during procedure(within 1 hour after birth)
- Total time spent with repair of episiotomy(within 1 hour after birth)
- Difficulties reported during procedure(within 1 hour after birth)
- Number of sutures and adhesive devices used(within 1 hour after birth)
- Wound complications(42-68 hours after delivery)
- Need to seek health facilities(30 days after delivery)
- Return of sexual activity(30 days after delivery)
研究者
研究点 (2)
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