Wound Eversion Versus Planar Closure for Wounds on the Face or Neck: a Randomized Split Wound Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Patient Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
The aim of this study is to determine whether wound edge eversion, achieved by careful placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the head or neck.
详细描述
It has been established that as wounds heal, the resultant tissue remodeling results in wound contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal sutures, there is less depression of the resultant scar. A prior study conducted by us at this center found that wound eversion was not associated with better cosmetic outcome (1). However, it was noted that most of the procedures were performed off the head and neck, places where the effects of eversion were thought to be most beneficial (2) Thus our goal is to now study the effects of eversion exclusively on the face and neck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
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
- •Patient scheduled for cutaneous surgical procedure with predicted linear closure on the face or neck
- •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
- •Pregnant Women
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Everted closure
Wound eversion will be achieved through buried vertical mattress suture or cuticular suture based on surgeon's preference, either buried vertical mattress suture or cuticular sutures
干预措施: Everted closure (Other)
Planar closure
The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures
干预措施: Planar closure (Other)
结局指标
主要结局
Patient Observer Scar Assessment Scale (POSAS)
时间窗: Within 3 months
The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
Incidence of sunken scars
时间窗: Within 3 months
The incidence of sunken scars or elevated scaring on each treatment side will also be determined
次要结局
未报告次要终点