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临床试验/NCT00681070
NCT00681070已完成不适用

Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2

Temple University4 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
4
主要终点
cosmetic outcomes

研究概览

简要总结

Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

详细描述

The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.

In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

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
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair

排除标准

  • Pregnancy
  • Endocrine problems
  • Dirty wounds
  • Irregular wounds

结局指标

主要结局

cosmetic outcomes

时间窗: 3 months

次要结局

  • infection(4-6 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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