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临床试验/NCT01770002
NCT01770002已完成不适用

Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

University of California, Davis1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Everted versus non-everted suturing techniques

研究概览

简要总结

The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, 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
否

入选标准

  • •Over 18 years of age
  • •Able to give informed consent themselves
  • •Willing to return for follow up visits

排除标准

  • •Mentally handicapped
  • •Unable to understand written and oral English
  • •Incarceration
  • •Under 18 years of age
  • •Unwilling to return for follow up
  • •Pregnant Women
  • •Wounds less than 3 cm in length

研究组 & 干预措施

Everted suture technique

Active Comparator

Technique that everts the skin; the edges will sit up against each other in a little peak, raised above the surrounding skin.

干预措施: Everted suture technique (Procedure)

Non-everted suture technique

Active Comparator

Surgical wound will be approximated such that the suture line is flat relative to the surrounding skin.

干预措施: Non-everted suture technique (Procedure)

结局指标

主要结局

Everted versus non-everted suturing techniques

时间窗: 3 and 6 months

Primary outcome measures for this study are the post operative scar width measured at 1 cm from the midline on both sides of the scar.

Mean score of sum of 2 blinded observers POSAS scores

时间窗: 3 and 6 months

The mean summed total of two blinded reviewers Physician Observer Scar Assessment Scale (POSAS) scores for each side of the wound.

Scar measurements (height, width, length)

时间窗: 3 and 6 months

Scar volume will be measured in centimeters on both sides of the wound

Scar induration

时间窗: 3 and 6 months

Scar induration area will be measured in centimeters for both sides of the wound

Scar erythema

时间窗: 3 and 6 months

Scar erythema area will be measured in centimeters for both sides of the wound

Wound contour irregularities

时间窗: 3 and 6 months

Wound contour irregularities will be measured in terms of volume in cubic centimeters via a length, width and height measurement

Stand cone volume

时间窗: 3 and 6 months

The volume of standing cones will be measured via length, width and height measurements in centimeters

Uneven edge measurement

时间窗: 3 and 6 months

The area of uneven edges will be measured via a length x height measurement in centimeters

Hyperpigmentation area

时间窗: 3 and 6 months

areas of hyperpigmentation will be measured via a length x width measurement in centimeters

次要结局

  • Infection(up to 6 months)
  • wound dehiscence(up to 6 months)
  • spitting sutures(3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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