跳至主要内容
临床试验/NCT05981443
NCT05981443已完成不适用

Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures

Cody Blanchard2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Number of Participants With Complications

研究概览

简要总结

The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are:

  • if Dermabond provides equivalent wound healing compared to conventional non-absorbable skin suture techniques
  • if Dermabond provides equivalent scar appearance compared to conventional non-absorbable suture techniques
  • if Dermabond results in equivalent complication rates compared to conventional non-absorbable suture techniques Participants will have be randomly selected to have either Dermabond or non-absorbable suture closure methods. Scar analysis and both participant and provider surveys will be performed to assess the differences between groups, if any.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing bilateral direct excision brow lift for brow ptosis at the University of Kentucky Medical Center.
  • Patients > 18 years of age.
  • Patients must be able to follow up at the specified intervals.
  • Patients who are able to give their own informed consent.
  • Health Status: Variable health status reflective of general population of Kentucky. Patients will be healthy enough to be seen in an office setting.
  • All patients will need to be proficient in the English language to understand the scale used for scar assessment

排除标准

  • Patients <18 years of age or >100
  • Allergy to Dermabond
  • Adults with impaired consent capacity
  • Incarcerated individuals

结局指标

主要结局

Number of Participants With Complications

时间窗: 6 weeks

Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection

Scar Appearance

时间窗: 6 weeks

Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.

次要结局

未报告次要终点

研究者

发起方
Cody Blanchard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cody Blanchard

Resident Physician, Ophthalmology

University of Kentucky

研究点 (2)

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