Cesarean Delivery Skin Closure: A Randomized Controlled Trial of Standard Staples Versus Absorbable Staples
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Post operative pain
研究概览
简要总结
We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause less pain, have better long-term cosmetic results, and result in improved patient satisfaction over standard metal staples. We expect to see no difference in wound complication rates with these two cesarean skin closure techniques.
详细描述
Type: Randomized controlled trial
Selection of Patients: All pregnant women, undergoing a primary (their first) cesarean delivery at Thomas Jefferson University Hospital will be offered randomization regardless of indication for cesarean delivery. Patients will be excluded from the study if they have a history of a previous cesarean delivery, history of a previous Pfannensteil skin incision for an indication other than for a cesarean delivery (i.e. myomectomy, laparotomy), or a planned vertical skin incision prior to randomization.
Randomization:
Patients will be randomized to skin closure with either the standard staples or the Insorb™ absorbable staple using a computer-generated random number sequence in blocks of six and ten. Allocation will be concealed in opaque, sealed study envelopes that are held on labor and delivery until after consent is obtained. Patients will not be masked as to the type of stapler used however, the investigator obtaining outcome data at six months will be masked.
Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients at TJUH undergoing primary cesarean delivery via Pfannenstiel incision
- •Surgeon willing to adhere to randomized skin staple category
排除标准
- •Known allergy to staples or suture
- •Vertical skin incision
- •Repeat cesarean deliveries
结局指标
主要结局
Post operative pain
次要结局
- Length of time of skin closure
- Costs
- Cosmetic outcome
- Wound disruption rate
- Infection rate
- Patient Satisfaction