Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.

Hospital Sao Joao2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2005年5月最近更新: 2009年2月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hospital Sao Joao
入组人数: 100
试验地点: 2
主要终点: Self-assessed perineal pain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

Hospital Sao Joao

申办方类型

Other

研究点 (2)

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