Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Wound Infection with each Wound Closure Technique
研究概览
简要总结
The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
详细描述
The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.
Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.
排除标准
- •Patient refusal to participate in the trial
研究组 & 干预措施
Primary Closure
Primary Closure is made after surgery.
干预措施: Primary Closure (Procedure)
Delayed Primary Closure
Delayed Primary Closure is made after at least 7 days.
干预措施: Delayed Primary Closure (Procedure)
Vacuum Assisted Closure
Vacuum Assisted Device is used in the wound.
干预措施: Vacuum Assisted Closure (Procedure)
结局指标
主要结局
Incidence of Surgical Wound Infection with each Wound Closure Technique
时间窗: Two months
Presence of infection was determined by a certified board physician according to CDC's Criteria for Defining a Surgical Site Infection.
次要结局
未报告次要终点
研究者
Eduardo Flores Villalba
Associated investigator
Tecnologico de Monterrey