SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- postoperative pain
研究概览
简要总结
This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.
详细描述
Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents
The optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public
Apparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without increase in pain and dyspareunia during the puerperium
This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous.
- •First and second degree perineal tear.
- •Normal not instrumental vaginal delivery; spontaneous not induced.
- •Patient willingness to randomize to episiotomy repair technique.
排除标准
- •Previously existing local infections or lesions.
- •Third and forth degrees perineal tear.
- •Maternal diseases interfere with wound healing or causing excessive bleeding (coagulopathy, collagen disease, diabetes mellitus, known immunodeficiency, immunosuppressive treatment).
- •Known hypersensitivity to adhesive materials
- •Maternal unwillingness to undergo randomization.
- •Participation in another intervention-trial with interference of intervention and/or outcome of this study.
结局指标
主要结局
postoperative pain
时间窗: During the procedure
pain experience will be evaluated during the procedure,, 6 hours and 12 hours after the procedure by Wong-Baker faces pain rating scale . During the second visit 7-10 days after delivery; pain and patient satisfaction will be evaluated and recorded, data may be collected by phone for those may not be able to come back for the second visit.
次要结局
- Postoperative pain(10 days after procedure)
- timing of procedure(During the procedure)
- wound healing.(10 days)
- wound sepsis(10 days)
研究者
Ahmed Abass
lecturer
Ain Shams University