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临床试验/NCT01655602
NCT01655602Unknown1 期

Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation

Siriraj Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
10
试验地点
2
主要终点
Changing of scar on the donor site during time courses

研究概览

简要总结

This study aim to compare cosmetic results between 3 trichophytic closure techniques for donor site (the trimming of upper, lower and both edge of linear incision) in hair transplantation.

详细描述

Strip harvesting technique, a conventional hair transplantation procedure, is widely used in the treatment of androgenetic alopecia for more than half a century. It provides less time-consuming, more feasible and more cost-effective comparing with follicular unit extraction (FUE) technique. However, linear scar at the donor site is also introduced.

The latest method to fine the scar at the donor site was invented and known as 'Trichophytic closure technique'. It can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.

This research is a pilot, split-wound comparison study of trichophytic closure techniques for donor site in hair transplantation.10 males, aged ≥ 25 years, who require strip harvesting follicular unit transplantation in the treatment of androgenetic alopecia will be enrolled. Preoperative and perioperative process will be conducted as standard procedure except wound closure technique. Each incision wound of donor site will be equally divided into 3 parts (marked with tattoos as Fig.2) and each part will be randomly treated with different trichophytic closure techniques as below.

  • The 1-millimetre trimming of upper edge of linear incision before wound closure
  • The 1-millimetre trimming of lower edge of linear incision before wound closure
  • The 0.5-millimetre trimming of both edge of linear incision before wound closure For evaluation, we have planned to assess both cosmetic results and side effects as shown in the table. ( Table 1 - image file ) After data collecting process, we have planned to analyze the demographic data, rate of infection and other side effects in a descriptive manner. However, the evaluation for cosmetic results will be analyzed by paired t-test in the same technique at different follow up period and by one-way ANOVA between each technique at the same follow up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age of 25 or more
  • Diagnosis of androgenetic alopecia
  • Do not response to conventional treatment and undergo hair transplantation surgery

排除标准

  • Have skin lesion at donor site
  • Psychological disturbance including trichotillomania
  • Anti-HIV positive

研究组 & 干预措施

upper edge trimming

Experimental

Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure

干预措施: Trichophytic closure upper edge trimming (Procedure)

lower edge trimming

Experimental

Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure

干预措施: Trichophytic closure lower edge trimming (Procedure)

Both edge trimming

Experimental

Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure

干预措施: Trichophytic closure both edge trimming (Procedure)

结局指标

主要结局

Changing of scar on the donor site during time courses

时间窗: 1 week, 4 week, 12 week, 24 week

* Hair density * Width of scar * Global photographic view (taken with Cannon 60D 18.0 Megapixels 100 mm macro lens) * Uninvolved dermatologist's assessment \* * Self assessment\*

次要结局

  • Number of Participants with wound complication(immediate, 1week, 4week, 12week, 24week)

研究者

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

Rattapon Thuangtong

Assistant Professor

Siriraj Hospital

研究点 (2)

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