Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Patient Scar Satisfaction Scale Score
研究概览
简要总结
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
详细描述
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18 years or older
- •All women scheduled for primary or repeat cesarean deliveries
- •All women undergoing intrapartum or antepartum cesarean delivery
- •Pfannenstiel skin incision
- •Birth of a live infant at time of cesarean delivery
排除标准
- •Vertical skin incision
- •Cesarean hysterectomy
- •Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc)
- •Intrapartum stillbirth
- •Planned postpartum follow up at another facility
- •Contraindications to routine postpartum pain medications
- •Adhesive or tape allergy
研究组 & 干预措施
Dermabond Prineo Group
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
干预措施: Dermabond Prineo (Device)
Suture Group
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
干预措施: Suture (Other)
结局指标
主要结局
Patient Scar Satisfaction Scale Score
时间窗: Assessed at 6-weeks postpartum
The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
次要结局
- Incidence of Surgical Site Infection (SSI)(Assessed during delivery hospitalization and at 6-week follow-up)
- Skin Closure Time(Intraoperative)
- Operative Time(Intraoperative)
研究者
Russell Miller
Sloane Hospital for Women Associate Professor of Prenatal Pediatrics
Columbia University