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临床试验/NCT01557491
NCT01557491Unknown不适用

A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
试验地点
2
主要终点
Hair Regrowth Within the Scar

研究概览

简要总结

Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. However, many factors may be confounders such as wound tension and cauterizing the incision. This study will investigate the effect a bevelled incision has on hair growth preservation compared to a standard incision that incises the skin perpendicular to its surface irrespective of hair follicle angles. Following informed voluntary consent, subjects who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right side of this bilateral incision will be randomized to receive either a bevelled or a standard incision and the left side will receive the opposite type. During routine surgical follow-up the hair growth within the scar of the two sides will be recorded for comparison and it is our hypothesis that the side with the bevelled incision will have more hair within the scar.

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

  • Bicoronal Incision required as part of surgical plan
  • Incision within hair-bearing scalp

排除标准

  • Previous Bicoronal Incision
  • Unfit for Surgery
  • Unable to provide informed consent
  • Unable to comply with followup
  • Preexisting alopecia of scalp
  • Cutaneous malignancy of scalp

研究组 & 干预措施

Straight Incision

Active Comparator

incision made perpendicular to scalp surface

干预措施: Straight Incision (Procedure)

Bevelled Incision

Active Comparator

Incision made at 45 degrees to scalp surface

干预措施: Bevelled Incision (Procedure)

结局指标

主要结局

Hair Regrowth Within the Scar

时间窗: 12 months

Hair growth through the scar will be counted at 6 and 12 month followup

次要结局

  • Scar Characteristics(1 year post surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jeff Fialkov

Craniofacial Surgeon

Sunnybrook Health Sciences Centre

研究点 (2)

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