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临床试验/NCT00524511
NCT00524511终止不适用

A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2007年9月1日最近更新:
适应症

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

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

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Tasillo

Assistant Professor

University of Massachusetts, Worcester

研究点 (2)

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