Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section
研究概览
简要总结
The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.
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
- Double (Participant, Investigator)
盲法说明
computer randomized list of closure type opened from a sealed envelope on the day of surgery
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age greater than 18
- •Elective cesarean section
- •Term pregnancy
排除标准
- •Fever >101F in the past 14 days
- •Antibiotics in the past 14 days
- •Suspected ongoing infection
- •Poorly controlled gestational diabetes
- •Allergic to adhesive
结局指标
主要结局
Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section
时间窗: 18 months
The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section
次要结局
- Total surgery time(18 months)
- Wound Infections as measured in centimeters of erythema(18 months)
- BMI(18 months)
- Pain Scores(18 months)
- Age(18 months)
- Wound separation as measured in centimeters(18 months)
- Patient Satisfaction scores(18 months)
- Ethnicity(18 months)
- Race(18 months)
研究者
Robert J. Rubino, MD, FACOG
Principal investigator , Assistant Clinical Professor
Rubino Ob-Gyn Group