Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- incidence of surgical site infection
研究概览
简要总结
A comparison of skin closure techniques (standard skin closure with staples versus a continuous (subcuticular) absorbable suture), to determine if this changes the rate of post operative wound infections in elective colorectal surgery patients.
详细描述
In colorectal surgery, there has been a growing interest in the study of Surgical Site Infections (SSI), with an outstanding variability of reported incidence, ranging from 3% up to 30% depending on the series. Although general risk factors for infection have been identified, there is still a need to identify specific risk factors for colorectal surgery patients, to try to reduce these numbers. The technique and materials used for wound closure have been considered as interesting variables for study.
Main question of our study: is subcuticular (reabsorbable, continuous) suture better than skin staples for reducing wound SSIs in colorectal surgery? The study is sponsored by the Surgical Infection Society Europe, and was awarded the SIS-E Fellowship for young investigators (2013)
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
- •Adults (age >18), both genders.
- •Elective colorectal surgery interventions
- •Open surgery incisions and laparoscopic extraction incisions
- •Incisions >5cm, any location
- •Intervention performed by a specialist colorectal surgeon
- •Patient suitable for surgery in preoperative assessment
- •Informed consent
排除标准
- •Emergency colorectal surgery
- •Scheduled multiple surgical procedures
- •Unsuitable preoperative assessment
- •Other infections present/being treated.
- •Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.)
- •Inability to understand the study/sign informed consent
研究组 & 干预措施
Subcuticular suture
Subcuticular suture (absorbable) for skin closure
干预措施: subcuticular suture (Procedure)
Skin staples
Standard skin staples for wound closure
干预措施: Skin staples (Procedure)
结局指标
主要结局
incidence of surgical site infection
时间窗: 30 days, as by CDC definition
The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.
次要结局
- prolongation of hospitalization(30 days)