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临床试验/NCT00938691
NCT00938691Unknown不适用

Optimal Suture Choice for Improved Scar Outcomes

Dallas VA Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Scar spread

研究概览

简要总结

Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring excision of a lesion on chest, back, or shoulders

排除标准

  • History of ionizing radiation
  • History of keloid or hypertrophic scarring
  • History of or current internal malignancy
  • History of bleeding disorder
  • History of collagen or elastin disorder
  • Current use of immunosuppressive medications

结局指标

主要结局

Scar spread

时间窗: 3 months and 1 year

次要结局

  • Scar appearance(3 months and 1 year)

研究者

申办方类型
Fed

研究点 (2)

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