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临床试验/NCT02130297
NCT02130297已完成不适用

Post Excision/Mohs Fractional CO2 Resurfacing: A Quantitative and Qualitative Scar Analysis Study

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
MMSS for Scar Halves Treated

研究概览

简要总结

The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.

详细描述

The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser.

There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.

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
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

入选标准

  • Must understand and voluntarily sign an informed consent form.
  • Must be male or female and aged >18 years at the time of consent.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Patients undergoing skin excisions of the face/trunk/extremities.

排除标准

  • Inability to provide voluntary informed consent
  • Use of laser or light based treatments to affected areas in past year
  • Fitzpatrick Skin types 3-5
  • Surgical lesions located on the central chest
  • History of keloid formation
  • History of Accutane in the last six months

结局指标

主要结局

MMSS for Scar Halves Treated

时间窗: Day 0 and Day 14

modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes

次要结局

  • Quartile Scale(24 weeks post-op)
  • Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity(Day 0 and Day 14)

研究者

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

Hooman Khorasani

Clinical Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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