A Prospective, Randomized Study to Evaluate the Efficacy of Pulley Closures Compared to Intermediate or Complex Closures for Reconstruction of Scalp Surgical Defects
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
- 是
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
This arm will have closures of scalp defects with deep and superficial suture placement.
干预措施: Intermediate Repair (Procedure)
Pulley stitches
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
David M. Ozog
Dermatologist
Henry Ford Health System
