A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Wound Complication Rate
研究概览
简要总结
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women undergoing scheduled and non-scheduled cesarean deliveries
排除标准
- •Prisoners
- •Insulin-requiring diabetics
- •Vertical skin incision
- •Allergy to Dermabond
结局指标
主要结局
Wound Complication Rate
时间窗: within six weeks of study intervention
Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
次要结局
- Patient Satisfaction of Cosmesis of Surgical Wound(before hospital discharge after surgery)
研究者
Dawn Tasillo
Assistant Professor
University of Massachusetts, Worcester
