Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?
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
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
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)
