Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Wound infection/separation
研究概览
简要总结
The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.
详细描述
Procedures:
A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use.
Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance.
Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cesarean sections
- •UT patients
排除标准
- •Patients who have skin closed with suture, per attending choice.
结局指标
主要结局
Wound infection/separation
时间窗: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.
次要结局
- wound hematoma(From time of surgery up until wound assessed to be completely healed, no longer than 1 year.)
- wound seroma(From time of surgery up until wound assessed to be completely healed, no longer than 1 year.)
研究者
Jonathan P Faro
Assistant Professor, ObGyn
The University of Texas Health Science Center, Houston