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临床试验/NCT05074199
NCT05074199已完成不适用

Comparison of Cosmetic Outcomes of Straight Line and W-plasty Techniques for Linear Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

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: 2018年2月26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
Patient Observer Scar Assessment Scale (POSAS) scores

研究概览

简要总结

The purpose of this study is to compare the cosmetic outcome of traditional straight-line (SL) linear closure to that of W plasty (a type of geometric broken-line cutaneous closure technique) for closure of post-auricular wounds resulting from harvest of full thickness skin grafts during Mohs micrographic surgery. The research team will use a split wound model, where half of the wound is repaired with a straight-line cutaneous closure and the other half is repaired with the W-plasty technique. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale (POSAS), a validated scar instrument. The scar width, and adverse events will also be recorded.

详细描述

Optimizing the cosmetic appearance of surgical scars is an important element of cutaneous surgery, especially for procedures performed on conspicuous areas of the body such as the head and face. Multiple factors have been shown to affect the aesthetic outcome of scars resulting from cutaneous surgery including the amount of tension on the resultant surgical wound, suture technique and type of sutures used. The use of various wound closure techniques including linear straight-line (SL) and geometric broken-line closure techniques (Z-plasty, W-plasty) to achieve a superior cosmetic scar outcome, has been debated in the dermatology and plastic surgery literature with few studies comparing SL and broken-line closure techniques and mixed results as to which modality provides a superior cosmetic outcome [2]. A study of forehead donor site closure in in 31 undergoing a paramedian forehead flap procedure showed that W-plasty provided a superior cosmetic outcome over straight-line closure, however another study in 30 patients undergoing tempo-parietal facial flaps found that W-plasty resulted in an inferior cosmetic outcome compared to linear closure. In addition, a large national survey of over 800 lay public participants found that linear scars were perceived as more cosmetically favorable than zig-zag scars in three facial locations (temple, cheek and forehead). Currently, there are no studies comparing the two closure techniques in a split-scar design, which can ameliorate many potentially confounding individual patient factors that could affect scar outcome.

Full-thickness skin grafts (FTSGs) are a commonly utilized reconstructive option in cutaneous surgery, and are typically harvested from behind the ear (postauricular) to close surgical defects on the head and face following surgical removal of both benign and malignant cutaneous tumors. This study aims to investigate whether the choice of straight-line linear closure versus a zig-zag broken line cutaneous closure technique (W-plasty) affects the cosmetic outcome of postauricular scars resulting from donor site closure following FTSG harvest. Additionally, skin lesions removed behind the ear present another opportunity to compare outcomes of these two techniques in an inconspicuous location.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (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

  • •18 years of age or older
  • •Able to give informed consent themselves
  • •Patient scheduled for cutaneous surgical procedure on the head or face for which a full thickness skin graft will be used as part of the reconstruction or has a lesion that will be excised in mastoid area of the neck, behind the ear.
  • •Willing to return for follow up visit.

排除标准

  • •Wounds predicted to be less than 3 cm in size after closure.
  • •Unable to understand written and oral English
  • •Incarceration
  • •Under 18 years of age
  • •Pregnant Women

研究组 & 干预措施

W-plasty

Active Comparator

The cosmetic appearance of scars closed in a in a "zig-zag" " fashion (W-plasty).

干预措施: W-plasty/Linear closure (Procedure)

Linear closure

Active Comparator

The cosmetic appearance of scars closed in a standard "straight line" fashion (linear closure).

干预措施: W-plasty/Linear closure (Procedure)

结局指标

主要结局

Patient Observer Scar Assessment Scale (POSAS) scores

时间窗: 3-12 months

The primary outcome is the difference in Patient Observer Scar Assessment Scale (POSAS) scores between the halves of the wound (standard linear closure versus W-plasty). The POSAS instrument incorporates separate questionnaires for observers and patients. Each questionnaire contains six items with possible scores from 0-10 for a total maximum score of 60 on each component (patient and observer).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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