Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial
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
- Severity of pain 6h postoperatively
研究概览
简要总结
This study will be done to question the superiority of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women..
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 an increase in pain and dyspareunia during the puerperium
This study will be commenced to question the advantage of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women.
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, Investigator, Outcomes Assessor)
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
- •primigravidae 18 years or older.
- •Spontaneous not induced full term normal not instrumental vaginal delivery with mediolateral episiotomy.
- •First and 2nd-degree perineal tear.
排除标准
- •• patients who had an instrumental delivery.
- •3rd and fourth-degree perineal tears.
- •those with local infectious lesions in the area to be repaired.
- •preexisting medical disorders as diabetes mellitus, severe pulmonary disease and collagen disease.
- •Immunosuppressive treatment.
- •known hypersensitivity to adhesive tape or materials.
- •Maternal unwillingness to undergo randomization.
结局指标
主要结局
Severity of pain 6h postoperatively
时间窗: 6 hours after the procedure
the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.
Severity of pain 12 hours postpartum
时间窗: 12 hours after the procedure
the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.
次要结局
- timing of procedure(During the procedure)
- wound healing(7-10 days after delivery)
- Severity of pain 10 days postpartum(10 days after procedure)
- Severity of pain immediately after episiotomy repair(immediately after the procedure)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University