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临床试验/NCT02744950
NCT02744950已完成不适用

A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年11月1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
21
试验地点
1
主要终点
Time to close wound

研究概览

简要总结

Surgical defects on the scalp require closure via various techniques of suture placement. A traditional technique requires both dermal (deep) and epidermal (superficial) placement of sutures to close the defect; this is referred to as intermediate or complex linear repair. However, the scalp is a location with high tension, and thus the closures take an hour or longer to perform. A type of suture placement referred to as the "pulley stitch" requires placement of a few stitches along the defect. The pulley stitch can be used in areas of high tension to close a large defect. The purpose of this study is to compare the scar results and time taken to perform scalp closures via only pulley stitches or via intermediate/complex linear repairs.

To my knowledge, no such study has been performed to compare the two techniques. Such a study would be useful in demonstrating comparable scar appearance and reduce the time to perform scalp closures.

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
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

入选标准

  • Age greater than 18 years
  • Ability to understand risks, benefits, and alternatives to the study and to be able to give an informed consent
  • Lesions such as skin cancer or benign lesions on the scalp amenable to surgical excision or to MOHS surgical technique
  • Frontal scalp defects defined as frontal hair line to crown of scalp
  • Scalp defect size of 2cm - 8 cm

排除标准

  • Patients who tend to form keloids or hypertrophic scars
  • Patients with a history of scleroderma or morphea
  • Pregnant or breast-feeding females
  • Patients whose surgical defects require flap closures

研究组 & 干预措施

Intermediate/complex repair

Active Comparator

This arm will have closures of scalp defects with deep and superficial suture placement.

干预措施: Intermediate Repair (Procedure)

Pulley stitches

Experimental

This arm of the study will have only pulley stitches to close the entire defect.

干预措施: Pulley stitches (Procedure)

结局指标

主要结局

Time to close wound

时间窗: Depends on case typically 4-10 minutes

Time it takes to close the defect in each arm; measured in minutes

次要结局

未报告次要终点

研究者

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

David M. Ozog

Dermatologist

Henry Ford Health System

研究点 (1)

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